ipd_sharing: No

acronym: ELEVATE UC 12

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Arena Pharmaceuticals

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Slovakia
Lebanon
Canada
Switzerland
Hungary
Germany
Bulgaria
Moldova, Republic of
Denmark
Belarus
Georgia
Estonia
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Washington University School of Medicine

location_facility: Instituto de Investigaciones Clínicas Quilmes SRL

location_facility: Medical College of Wisconsin Clinical Trials Office

location_facility: Medical center "Nov Rehabilitatsionen Tsentar" EOOD

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care

location_facility: Stavropol Regional Clinical Diagnostic Centre

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center

location_facility: RTL SM SRL, Institutia Medico- Sanitara Publica Spitalul Clinic, Sectia Proctologie

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: KH der Barmherzigen Brüder Linz, Interne Abteilung

location_facility: Government Medical College and Super Speciality Hospital

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: Great Lakes Medical Research, LLC - Harrisburg

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Berner IBD study group c/o Gastroenterologische Praxis Balsiger, Seibold &Partner

location_facility: Republican Clinical Hospital, ARENSIA Exploratory Medicine

location_facility: Iwate Medical University Uchimaru Medical Center

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Children's Center for Digestive Health Care, LLC

location_facility: Charité Universitätsmedizin Berlin - Campus Charité Mitte

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

location_facility: Semmelweis Egyetem, II.sz. Belgyogyaszati Klinika

location_facility: Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

location_facility: Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"

location_facility: Hôpital Rangueil Service Gastro-entérologie et pancreatologie

location_facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"

location_facility: SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: S.C Delta Health Care S.R.L, Ponderas Academic Hospital

location_facility: Allmedica Badania Kliniczne Sp. z o.o. Sp.k.

location_facility: Hospital General Universitario de Alicante

location_facility: Severance Hospital, Yonsei University Health System

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Odesa regional clinical hospital, regional center of gastroenterology, surgical department

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: General Hospital "Dr. Tomislav Bardek" Koprivnica

location_facility: Diagnostic-Consultative Center I - Sliven, EOOD

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: UAB "Inlita", Santaros Clinical Trials Centre

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: LTD Acad. F. Todua Medical Centre, LTD. Research Institution of Clinical Medicine

location_facility: State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"

location_facility: Great Lakes Medical Research, LLC - Mentor

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: The University of Texas at Austin Dell Medical School

location_facility: Fundación Respirar- Centro Médico Dra. De Salvo

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Dr. Peter Bossuyt - GI Clinical Research Center

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Aalborg University Hospital, department of medical gastroenterology

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: Gastromed Kralisz, Romatowski, Stachurska sp.j

location_facility: Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU

location_facility: Tokushukai Kishiwada Tokushukai Hospital

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: A.O. Ordine Mauriziano di Torino - P.O. Ospedale Umberto I

location_facility: Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E

location_facility: Spitalul Clinic Judetean de Urgenta Craiova

location_facility: Republican Panevezys Hospital, Department of Gastroenterology

location_facility: LTD Israeli-Georgian medical research clinic Helsicore

location_facility: LTD Central University Clinic After Academic N. Kipshidze

location_facility: Marshall University Department of Clinical Research

location_facility: American University of Beirut Medical Center

location_facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"

location_facility: Japan Community Health care Organization Osaka Hospital

location_facility: Shiga University of Medical Science Hospital

location_facility: Inselspital, Gaby Saner, Gastroenterologie, Bauchzentrum

location_facility: Hospital San Juan de Dios Fundacion Cardiomet-Cequin

location_facility: Clinica de la Mujer Centro de Investigaciones

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: Kocaeli University Research and Training Hospital

location_facility: Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel

location_facility: Medical Clinical Investigational Center of Medical Center Health Clinic LLC

location_facility: Postgraduate department of Medicine, GSVM Medical college

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center

location_facility: Clinica farallones centro de investigaciones clinicas CIC

location_facility: FSBI of higher Education "First Saint Petersburg State Medical University n.a. I.P.Pavlov

location_facility: Digestive Health Specialists of the Southeast

location_facility: Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University

location_facility: Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council

location_facility: Karkonoskie Centrum Badan Klinicznych Lexmedica

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Institution "Gomel Regional Clinical Hospital"

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council, Ga

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Saint George Hospital University Medical Center

location_facility: Dept of Gastroenterology, Szent Gyorgy Hospital

location_facility: Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology

location_facility: SZTE AOK I.st dept. of Internal Medicine.

location_facility: Guy's and Saint Thomas NHS Foundation Trust

location_facility: Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia

location_facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi

location_facility: EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji

location_facility: University Hospital Antwerp Gastroenterology and Hepatology Department

location_facility: LLC "Multidisciplinary Medical Clinic "Anthurium"

summary: The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).


title: A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease

acronym: CULTIVATE

summary: This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the 28-Day Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Norway
Malaysia
Slovakia
Egypt
Bosnia and Herzegovina
Lebanon
Canada
Switzerland
Hungary
Germany
Bulgaria
Moldova, Republic of
Denmark
Belarus
Greece
Georgia
Ireland
Latvia
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Southern Therapy and Advanced Research, LLC

location_facility: Washington University School of Medicine

location_facility: North-Western Medical University n.a. I.I. Mechnikov of Ministry of Healthcare of Russian Federation

location_facility: Medical College of Wisconsin Clinical Trials Office

location_facility: Ospedale San Bortolo di Vicenza, , Gastroenterologia

location_facility: Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council

location_facility: Stavropol Regional Clinical Diagnostic Centre

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: University General Hospital of Alexandroupoli

location_facility: McGill University Health Centre/Glen Site / Royal Victoria Hospital

location_facility: Midas Multispeciality Hospital Pvt. Ltd.

location_facility: University Clinical Hospital Mostar, Department of gastroenterology

location_facility: Centro de Investigaciones Clínicas S.A.S

location_facility: Krishna Institute of Medical Sciences Limited (KIMS Hospital)

location_facility: Clarunis Universitares Bauchzentrum Basel

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: P. Stradins Clinical University Hospital

location_facility: Hopital Saint Eloi Pole Digestif Hgea Recherche Clinique Rdc

location_facility: Sf. Arhanghel Mihail" Municipal Clinical Hospital

location_facility: PMSI Republican Clinical Hospital "Timofei Mosneaga", Outpatient Department

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza, S.C. Gastroenterologia ed Endoscopia Digestiva

location_facility: Asclepiades - interna a gastroenterologie s. r. o.

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Institute of Gastroenterology and Liver Diseases,Tel Aviv Sourasky Medical Center

location_facility: Vinnytsia M.I.Pyrogov Regional Clinical Hospital of Vinnytsia Regional Council

location_facility: Alexandria Clinical Research Center, Faculty of Medicine, Alexandria University

location_facility: Communal Noncommercial Enterprise Lviv Clinical Emergency Hospital

location_facility: Gujarat Hospital, Gastro and Vascular Centre

location_facility: S. R. Kalla Memorial Gastro & General Hospital

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie, Sectia Gastroenterologie II

location_facility: Hospital of University of Occupational and Environmental Health

location_facility: Centro Hospitalar Universitário de São João, EPE

location_facility: Centro de Investigaciones Médicas Mar del Plata

location_facility: Centro de Investigacion Medico Bilogica y Terapia Avanzada s.c.

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: PMSI "Sfanta Treime" Municipal Clinical Hospital

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: S.C. Quantum Medical Center S.R.L. Specialitatea Gastroenterologie

location_facility: Penn State Health Milton S.Hershey Medical Center

location_facility: Egyptian Liver Research Institute and Hospital (ELRIAH)

location_facility: Allmedica Badania Kliniczne Sp. z o.o. Sp.k.

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: The Catholic University of Korea, Daejeon St. Mary's Hospital

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza, 4. Belgyógyászat-Gasztroenterológia-Hepatológ

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. jawna

location_facility: Akershus universitetssykehus, Avdeling for Fordøyelsessykdommer

location_facility: Guthrie Clinical Research/Guthrie Foundation

location_facility: The University of Texas at Austin Dell Medical School

location_facility: Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University

location_facility: Allied Health Clinical Research Organization

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: San Diego Gastroenterology Medical Associates

location_facility: Illinois Gastroenterology Group - Arlington Heights

location_facility: Servicios Médicos y de Investigación Clínica InspirePharma S de R L de CV.

location_facility: Agaplesion Markus-Krankenhaus Medizinische Klinik I Studienzentrale

location_facility: Saint George University Hospital Medical Center

location_facility: Anticancer-Oncology Hospital of Athens "Agios Savvas"

location_facility: T.C. Saglik Bakanligi Ankara Sehir Hastanesi

location_facility: I.R.C.C.S Saverio De Bellis, UOC Gastroenterologia II

location_facility: Specjalistyczne Gabinety Lekarskie LANDA

location_facility: LTD Central University Clinic After Academic N. Kipshidze

location_facility: Marshall University Department of Clinical Research

location_facility: National Hepatology and Tropical Medicine Research Institute

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD

location_facility: Hammoud Hospital University Medical Center

location_facility: Inselspital, University Hospital for Gastroenterology, Abdominal Center

location_facility: Japan Community Health care Organization Osaka Hospital

location_facility: Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council, D

location_facility: The University of Texas Health Science Center at Houston (UTHealth)

location_facility: Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Kocaeli University Research and Training Hospital

location_facility: Karkonoskie Centrum Badan Klinicznych - Lexmedica

location_facility: Clinical Hospital Center -Dr Dragisa Misovic-Dedinje

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Medical Center of Limited Liability Company Harmoniia Krasy

location_facility: Communal Noncommercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology

location_facility: PMSI "Timofei Mosneaga" Republican Clinical Hospital

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente

location_facility: Fiona Stanley Hospital-Harry Perkins Building

location_facility: University General Hospital of Heraklion, Gastroenterology Department

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: Baylor College of Medicine - McNair Campus

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: U.O.C. Gastroenterologia ed Endoscopia Digestiva

location_facility: Ponce Medical school Foundation, Inc CAIMED Center

location_facility: University of California San Diego Medical Center

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: General Hospital of Athens of Chest Diseases Sotiria, C Internal Medicine Clinic

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Azienda Ospedaliero-Universitaria Sant 'Andrea UOC Malattie dell'a arato di erente

location_facility: PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Colorectal Surgery

location_facility: Centro Ricerche Cliniche c/o Policlinico G.B.Rossi, Borgo Roma

location_facility: Macquarie University Hospital Clinical Trials

location_facility: Medical University Innsbruck, Internal Medicine I

location_facility: UF Health Jacksonville Gastroenterology-Emerson

location_facility: S.C. Centrul Medical Unirea S.R.L., Specialitatea Gastroenterologie

location_facility: SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie

location_facility: AKH Wien- Universitätsklinik für Innere Medizin III Klinische Abteilung für Gastroenterologie & Hepa

location_facility: CHA Bundang Medical Center, CHA University

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Phase III Study Evaluating the Use of Systemic Chemotherapy and Chemohyperthemia Intraperitoneal Preoperatively (CHIP) and After Maximum Resection of Peritoneal Carcinomatosis Originating With Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether systemic chemotherapy is more effective with or without intraperitoneal chemohyperthermia in treating patients with peritoneal carcinomatosis from colorectal cancer.

PURPOSE: This randomized phase III trial is studying systemic chemotherapy to see how well it works compared with or without intraperitoneal chemohyperthermia in treating patients undergoing surgery for peritoneal carcinomatosis from colorectal cancer.

status: Completed

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Quénet F, Elias D, Roca L, Goéré D, Ghouti L, Pocard M, Facy O, Arvieux C, Lorimier G, Pezet D, Marchal F, Loi V, Meeus P, Juzyna B, de Forges H, Paineau J, Glehen O; UNICANCER-GI Group and BIG Renape Group. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):256-266. doi: 10.1016/S1470-2045(20)30599-4. Epub 2021 Jan 18.

lead_sponsor: UNICANCER

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

intervention_type: Procedure

status_simplified: Completed


type: Other Identifier

type: Registry Identifier

type: EudraCT Number

title: A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, Formerly PT2977) Monotherapy in Participants With Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), or Von Hippel-Lindau (VHL) Disease-Associated Tumors

summary: This is a study to evaluate the efficacy and safety of Belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET) or von Hippel-Lindau (VHL) Disease-Associated Tumors. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Denmark
Spain
Italy
Russian Federation
United Kingdom
Canada
Sweden
Hungary
United States
France
Turkey
Germany

location_facility: Ege University Medicine of Faculty ( Site 0900)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)

location_facility: Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)

location_facility: Washington University-Internal Medicine/Oncology ( Site 0124)

location_facility: Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)

location_facility: Hôpital Edouard Herriot-oncologie ( Site 0405)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1202)

location_facility: Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 1308)

location_facility: Hammersmith Hospital-Medical Oncology ( Site 1304)

location_facility: Cedars-Sinai Medical Center ( Site 0110)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0123)

location_facility: Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (

location_facility: Vanderbilt University Medical Center ( Site 0107)

location_facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe

location_facility: Hospital Universitari Vall d'Hebron ( Site 1100)

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)

location_facility: University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)

location_facility: GBUZ Republican Clinical Oncological Dispensary ( Site 0804)

location_facility: Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division (

location_facility: Hacettepe Universitesi-oncology hospital ( Site 0901)

location_facility: Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)

location_facility: Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)

location_facility: MD Anderson Cancer Center-Oncology ( Site 1102)

location_facility: University of Texas MD Anderson Cancer Center ( Site 0112)

location_facility: Odense Universitetshospital ( Site 0302)

location_facility: Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site

location_facility: Princess Margaret Cancer Centre ( Site 0202)

location_facility: Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site

location_facility: Universitaetsklinikum Freiburg ( Site 0504)

location_facility: Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)

location_facility: Rigshospitalet-Department of Endocrinology ( Site 0303)

location_facility: CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)

location_facility: Skanes University Hospital Lund ( Site 1200)

location_facility: Institut Paoli-Calmettes-Oncology ( Site 0406)

location_facility: Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)

location_facility: Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)


title: A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection

lead_sponsor: AbbVie

source: euctr

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Spain
Italy
Austria
Australia
Canada
United States
France
Germany

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985

location_facility: Hospital General Universitario de Valencia /ID# 226709

location_facility: The Institute for Liver Health /ID# 228427

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 226783

location_facility: Midway Immunology and Research /ID# 229194

location_facility: University of Mississippi Medical Center /ID# 232620

location_facility: Vancouver Infectious Diseases Centre /ID# 227125

location_facility: Weill Cornell Medical College /ID# 230815

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 227183

location_facility: Hospital Clinic de Barcelona /ID# 226695

location_facility: AP-HP - Hopital Saint-Antoine /ID# 229070

location_facility: Medizinische Universitaet Wien /ID# 226938

location_facility: University of Iowa Hospitals and Clinics /ID# 226934

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 227081

location_facility: Angels Clinical Research Institute /ID# 234090

location_facility: HCL - Hopital de la Croix-Rousse /ID# 229077

location_facility: University of Kentucky Chandler Medical Center /ID# 231588

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 227079

location_facility: ICH Study Center GmbH & Co KG /ID# 228162

location_facility: Vanderbilt University Medical Center /ID# 241282

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 229083

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 226698

location_facility: zibp-Zentrum fuer Infektiologie /ID# 226765

location_facility: Velocity Clinical Research Chula Vista /ID# 238352

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 230814

location_facility: North Jersey Community Research Initiative (NJCRI) /ID# 245129

location_facility: Emory Midtown Infectious Disease Clinic /ID# 229927

location_facility: University of Louisville Research Foundation Inc /ID# 232139

location_facility: Liver Associates of Texas, P.A /ID# 229775

location_facility: Medical College of Wisconsin - Plank Rd /ID# 230116

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 227078

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 227080

location_facility: Hospital Parc de Salut del Mar /ID# 226696

location_facility: Cherokee Nation Outpatient Health Center /ID# 232618

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 227126

location_facility: Universitaetsklinikum St. Poelten /ID# 227098

location_facility: Digestive and Liver Disease Sp /ID# 232633

summary:
Hepatitis C Virus (HCV) infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection.

GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide.

Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.


title: A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors

summary:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed.

ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world.

In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28-day cycle.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires.

design_allocation: Non-Randomized

location_country:
Taiwan
Spain
Australia
Korea, Republic of
United States
Israel
France
Japan

location_facility: Carolina BioOncology Institute /ID# 225358

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 225975

location_facility: National Cancer Center Hospital /ID# 225724

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 243345

location_facility: National Cheng Kung University Hospital /ID# 225944

location_facility: Lifespan Cancer Institute at Rhode Island Hospital /ID# 226145

location_facility: Virginia Cancer Specialists - Fairfax /ID# 225693

location_facility: Hospital Universitario 12 de Octubre /ID# 225977

location_facility: National Taiwan University Hospital - Hsinchu branch /ID# 243610

location_facility: Hospital Universitario Vall d'Hebron /ID# 225976

location_facility: National Cancer Center Hospital East /ID# 225725

location_facility: AP-HM - Hopital de la Timone /ID# 225779

location_facility: Washington University-School of Medicine /ID# 225698

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 226096

location_facility: Dana-Farber Cancer Institute /ID# 231209

location_facility: Linkou Chang Gung Memorial Hospital /ID# 225946

location_facility: South Texas Accelerated Research Therapeutics /ID# 225359

location_facility: Centre Georges François Leclerc /ID# 226760

location_facility: Yonsei University Health System Severance Hospital /ID# 233774

location_facility: The Chaim Sheba Medical Center /ID# 225585

location_facility: Hospital Universitario Virgen de la Victoria /ID# 225978

location_facility: National Hospital Organization Shikoku Cancer Center /ID# 240821

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 240761


intervention_type: Biological

acronym: Ph 1/2 Substudy of Oncological Treatment(s) in PD-1 naïve or PD-1 exposed participants with MBM

title: A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02D

location_country:
Spain
Italy
Australia
Switzerland
United States
Israel
France
South Africa

location_facility: Centre Hospitalier Lyon Sud ( Site 4102)

location_facility: HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4399)

location_facility: Providence Saint John's Health Center ( Site 4010)

location_facility: Ohio State University Comprehensive Cancer Center ( Site 4020)

location_facility: Melanoma Institute Australia ( Site 4402)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 4012)

location_facility: Hadassah Ein Karem Jerusalem ( Site 4702)

location_facility: Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 4603)

location_facility: LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4861)

location_facility: CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 4865)

location_facility: Rabin Medical Center-Oncology ( Site 4705)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 4355)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 4108)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 4022)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 4377)

location_facility: The Angeles Clinic and Research Institute ( Site 4009)

location_facility: Istituto Europeo di Oncologia ( Site 4301)

location_facility: Inova Schar Cancer Institute ( Site 4011)

location_facility: Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 4863)

location_facility: Universitaetsspital Zuerich ( Site 4601)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 4302)

location_facility: Hospital Universitario Ramón y Cajal ( Site 4802)

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 4602)

location_facility: Rambam Health Care Campus-Oncology ( Site 4704)

summary:
Substudy 02D is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02D is to evaluate the safety and efficacy of investigational treatment arms in programmed cell-death 1 (PD-1) naïve or PD-1 exposed participants with melanoma brain metastasis (MBM) and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.


title: A Randomised, Controlled, Open-label, French Multicenter Parallel Group Study to Compare the Maintenance of Haemoglobin Level With Once Monthly Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Haemodialysis

summary: This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. Participants will be randomized to receive either monthly intravenous (IV) or subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (IV or SC epoetin beta once, twice or thrice weekly, or IV or SC darbepoetin alfa once a week or twice a week).

study_completion_date_type: Actual

ReferenceCitation: Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

lead_sponsor: Hoffmann-La Roche


title: A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02C

summary:
Substudy 02C is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.

location_country:
Italy
Australia
Switzerland
United States
Israel
France

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 3602)

location_facility: West Cancer Center - East Campus ( Site 3014)

location_facility: Universitaetsspital Zuerich ( Site 3601)

location_facility: Melanoma Institute Australia ( Site 3402)

location_facility: Centre Hospitalier Lyon Sud ( Site 3102)

location_facility: University of Pennsylvania Abramson Cancer Center ( Site 3008)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 3377)

location_facility: Hadassah Ein Karem Jerusalem ( Site 3702)

location_facility: Istituto Europeo di Oncologia ( Site 3301)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 3012)

location_facility: Providence Saint John's Health Center ( Site 3010)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 3107)

location_facility: The Angeles Clinic and Research Institute ( Site 3009)

location_facility: Rabin Medical Center-Oncology ( Site 3705)

location_facility: Oregon Health & Science University ( Site 3013)

location_facility: Tasman Oncology Research Pty Ltd ( Site 3403)

location_facility: Inova Schar Cancer Institute ( Site 3011)

location_facility: Rambam Health Care Campus-Oncology ( Site 3704)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 3022)


title: A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the Prevention of Oral Persistent Infection With HPV Types 16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of Age

summary: The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9-valent human papillomavirus (9vHPV) vaccine in men 20 to 45 years of age. The primary hypothesis tested in this study is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of HPV 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo.

status: Active, not recruiting

primary_purpose: Prevention

ReferenceCitation: Giuliano AR. Initiation of three complementary international studies investigating prevalence of oral HPV infection, burden of HPV-related head and neck disease, and efficacy of 9-valent HPV vaccination against oral HPV persistent infection. Contemp Clin Trials. 2022 Apr;115:106629. doi: 10.1016/j.cct.2021.106629. Epub 2021 Nov 24.

ReferenceCitation: Morais E, Kothari S, Roberts C, Yen G, Chen YT, Lynam M, Pedrós M, Mirghani H, Alemany L, Pavon MA, Waterboer T, Mehanna H, Giuliano AR. Oral human papillomavirus (HPV) and associated factors among healthy populations: The design of the PROGRESS (PRevalence of Oral hpv infection, a Global aSSessment) study. Contemp Clin Trials. 2022 Apr;115:106630. doi: 10.1016/j.cct.2021.106630. Epub 2021 Nov 25.

ReferenceCitation: Giuliano AR, Wilkin T, Bautista OM, Cheon K, Connor L, Dubey S; Thomas Group, Luxembourg A, Rawat S, Shaw A, Velicer C, Vendetti N, Tu Y. Design of a phase III efficacy, immunogenicity, and safety study of 9-valent human papillomavirus vaccine in prevention of oral persistent infection in men. Contemp Clin Trials. 2022 Apr;115:106592. doi: 10.1016/j.cct.2021.106592. Epub 2021 Oct 19.

location_country:
Taiwan
Brazil
Belgium
Spain
Italy
Mexico
Thailand
Korea, Republic of
United States
France
Israel
Peru
Colombia
Japan
Germany
Czechia

location_facility: Healthcare Research Network LLC ( Site 0035)

location_facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 0954)

location_facility: Medical Corporation Iseikai My City Clinic ( Site 1108)

location_facility: Instituto de Investigacion Nutricional - Anexo Huascar ( Site 0251)

location_facility: Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102)

location_facility: Charlottesville Medical Research Center, LLC ( Site 0007)

location_facility: Alliance for Multispecialty Reseach, LLC ( Site 0021)

location_facility: CHU Nantes - Hopital Hotel Dieu ( Site 0510)

location_facility: Azienda Ospedaliera - Universita di Padova ( Site 0555)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1003)

location_facility: Coastal Carolina Research Center ( Site 0043)

location_facility: Encompass Clinical Research ( Site 0028)

location_facility: Heartland Research Associates, LLC ( Site 0034)

location_facility: J Lewis Research Inc/Foothill Family Clinic South ( Site 0006)

location_facility: Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1106)

location_facility: Korea University Guro Hospital ( Site 0950)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0153)

location_facility: Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0551)

location_facility: Cotton-O'Neil Clinical Research Center ( Site 0044)

location_facility: Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1102)

location_facility: Medical Corporation Heishinkai OPHAC Hospital ( Site 1105)

location_facility: Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0156)

location_facility: Kentucky Pediatric/Adult Research Inc ( Site 0011)

location_facility: ARKE Estudios Clinicos S.A de C.V ( Site 0211)

location_facility: Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 1112)

location_facility: Armed Forces Research Institute of Medical Sciences ( Site 1051)

location_facility: Arke Estudios Clinicos S.A. de C.V. ( Site 0203)

location_facility: Certified Research Associates ( Site 0041)

location_facility: Medical Corporation Seiwakai Hayakawa Clinic ( Site 1113)

location_facility: Policlinico Universidad Nacional Mayor de San Marcos ( Site 0257)

location_facility: Acevedo Clinical Research Associates ( Site 0001)

location_facility: Investigaciones Medicas en Salud - INMENSA ( Site 0255)

location_facility: Vaccine Trial Center Faculty of Tropical Medicine ( Site 1052)

location_facility: Azienda Ospedaliera Policlinico di Bari ( Site 0550)

location_facility: Alta California Medical Group ( Site 0031)

location_facility: Universitatsklinikum Hamburg-Eppendorf ( Site 0451)

location_facility: Icaro Investigaciones en Medicina S.A. de C.V. ( Site 0200)

location_facility: Hallym University Kangnam Sacred Heart Hospital ( Site 0951)

location_facility: National Cheng Kung University Hospital ( Site 1002)

location_facility: Asociacion Civil Selva Amazonica ( Site 0252)

location_facility: Diablo Clinical Research, Inc ( Site 0042)

location_facility: Universita di Roma "La Sapienza" ( Site 0553)

location_facility: Research Institute for Health Sciences ( Site 1053)

location_facility: University of Texas Medical Branch at Galveston ( Site 0038)

location_facility: Rochester Clinical Research, Inc. ( Site 0008)

location_facility: Preferred Primary Care Physicians ( Site 0032)

location_facility: P-One Clinic, Keikokai Medical Corp. ( Site 1101)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 1050)

location_facility: J Lewis Research Inc/Jordan River Family Medicine ( Site 0023)

location_facility: Chang Gung Medical Foundation.Linkou Branch ( Site 1001)

location_facility: CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0223)

location_facility: Infektiologikum Frankfurt-Sachsenhausen ( Site 0456)

location_facility: Centrum ambulantni gynekologie a primarni pece ( Site 0401)

location_facility: Valley Clinical Trials Inc. ( Site 0002)

location_facility: Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 1111)

location_facility: Maccabi Health Services Medical Center ( Site 0604)

location_facility: Korea University Ansan Hospital ( Site 0952)

location_facility: Inland Empire Clinical Trials, LLC ( Site 0025)

location_facility: Solaris Clinical Research, LLC ( Site 0003)

location_facility: AOU Policlinico Vittorio Emanuele ( Site 0552)

location_facility: Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0101)

location_facility: Clinical Research Partners, LLC. ( Site 0004)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0600)

location_facility: Texas Center For Drug Development ( Site 0013)

location_facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0507)

location_facility: Crossroads Clinical Research LLC ( Site 0027)

location_facility: Clinical Research of South Florida ( Site 0036)

location_facility: Souseikai Nishikumamoto Hospital ( Site 1104)

location_facility: Rapid Medical Research, Inc. ( Site 0037)

location_facility: National Taiwan University Hospital ( Site 1000)

location_facility: Health Research of Hampton Roads, Inc. ( Site 0015)

location_facility: Instituto Nacional de Salud Publica ( Site 0202)

location_facility: Universitair Ziekenhuis Gasthuisberg ( Site 0353)

location_facility: Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0755)


acronym: LIBER

title: Prevention of Breast Cancer by Letrozole in Post-menopausal Women Carrying a BRCA1/BRCA2 Mutation

publications_result: Pujol P, Mijonnet S, Karen S, et al.: Breast cancer prevention by letrozole in post menopausal BRCA1/2 mutations carriers: The Onco-03/LIBER trial. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-1048, 2009.

ReferenceType: background

ReferenceCitation: Pujol P, Lasset C, Berthet P, Dugast C, Delaloge S, Fricker JP, Tennevet I, Chabbert-Buffet N, This P, Baudry K, Lemonnier J, Roca L, Mijonnet S, Gesta P, Chiesa J, Dreyfus H, Vennin P, Delnatte C, Bignon YJ, Lortholary A, Prieur F, Gladieff L, Lesur A, Clough KB, Nogues C, Martin AL; French Federation of Cancer Centres (FNCLCC). Uptake of a randomized breast cancer prevention trial comparing letrozole to placebo in BRCA1/2 mutations carriers: the LIBER trial. Fam Cancer. 2012 Mar;11(1):77-84. doi: 10.1007/s10689-011-9484-4.

ReferenceType: result

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

summary:
RATIONALE: Letrozole may prevent breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in preventing breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.


intervention_type: Radiation

acronym: NON APPLICABLE

title: Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk.

ReferenceCitation: Sargos P, Chabaud S, Latorzeff I, Magné N, Benyoucef A, Supiot S, Pasquier D, Abdiche MS, Gilliot O, Graff-Cailleaud P, Silva M, Bergerot P, Baumann P, Belkacemi Y, Azria D, Brihoum M, Soulié M, Richaud P. Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1341-1352. doi: 10.1016/S1470-2045(20)30454-X.

ReferenceCitation: Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prisé E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

summary:
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer.


ipd_sharing: Undecided

acronym: MAPS

title: A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

ReferenceCitation: Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24.

ReferenceCitation: Brosseau S, Danel C, Scherpereel A, Mazières J, Lantuejoul S, Margery J, Greillier L, Audigier-Valette C, Gounant V, Antoine M, Moro-Sibilot D, Rouquette I, Molinier O, Corre R, Monnet I, Langlais A, Morin F, Bergot E, Zalcman G, Levallet G. Shorter Survival in Malignant Pleural Mesothelioma Patients With High PD-L1 Expression Associated With Sarcomatoid or Biphasic Histology Subtype: A Series of 214 Cases From the Bio-MAPS Cohort. Clin Lung Cancer. 2019 Sep;20(5):e564-e575. doi: 10.1016/j.cllc.2019.04.010. Epub 2019 May 13.

ReferenceCitation: Ribi K, Luo W, Colleoni M, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Di Lauro V, Gomez HL, Ruhstaller T, Abdi E, Biganzoli L, Müller B, Barbeaux A, Graas MP, Rabaglio M, Francis PA, Foukakis T, Pagani O, Graiff C, Vorobiof D, Maibach R, Di Leo A, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J; SOLE Investigators. Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer. 2019 May;120(10):959-967. doi: 10.1038/s41416-019-0435-4. Epub 2019 Apr 10. Erratum in: Br J Cancer. 2020 Jan 16;:.

location_facility: Boujan sur Libron - Polyclinique Saint-Privat

summary: Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.


title: Azithromycin (Zithromax®) 5 Days Versus Amoxicillin-Clavulanic Acid (Augmentin®): Multicentre, Randomised, Open-Label Study To Compare The Clinical Efficacy And Safety Of Azithromycin With Those Of Amoxicillin-Clavulanic Acid In Patients Presenting With An Exacerbation Of Chronic Bronchitis

summary: This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.

lead_sponsor: Pfizer


acronym: PRADO

title: A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis

summary: This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.


title: A 12-Week Double-blind, Randomised, Placebo-controlled, Parallel Group Phase III Study, Followed by a 4-Week Randomised Withdrawal Period to Evaluate the Efficacy and Safety of Oral Ibodutant 10 mg Once Daily in Female Patients With Irritable Bowel Syndrome With Diarrhea

summary: Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.

lead_sponsor: Menarini Group

location_country:
Poland
Spain
Italy
Russian Federation
United Kingdom
Czech Republic
United States
France
Romania
Germany
Bulgaria


title: Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm

summary:
The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).

Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month.

The number of patients required in this multicentric and prospective study is 240 (16 participating centers).

primary_purpose: Diagnostic

ReferenceCitation: Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995 Apr 6;332(14):901-6.

ReferenceCitation: Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8.

ReferenceCitation: Ververs JM, Roumen RM, Vingerhoets AJ, Vreugdenhil G, Coebergh JW, Crommelin MA, Luiten EJ, Repelaer van Driel OJ, Schijven M, Wissing JC, Voogd AC. Risk, severity and predictors of physical and psychological morbidity after axillary lymph node dissection for breast cancer. Eur J Cancer. 2001 May;37(8):991-9.

ReferenceCitation: Kissin MW, Querci della Rovere G, Easton D, Westbury G. Risk of lymphoedema following the treatment of breast cancer. Br J Surg. 1986 Jul;73(7):580-4.

ReferenceCitation: Giuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994 Sep;220(3):391-8; discussion 398-401.

ReferenceCitation: Krag DN, Weaver DL, Alex JC, Fairbank JT. Surgical resection and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol. 1993 Dec;2(6):335-9; discussion 340.

ReferenceCitation: Glass EC, Essner R, Giuliano AE. Sentinel node localization in breast cancer. Semin Nucl Med. 1999 Jan;29(1):57-68. Review.

ReferenceCitation: Turner RR, Ollila DW, Krasne DL, Giuliano AE. Histopathologic validation of the sentinel lymph node hypothesis for breast carcinoma. Ann Surg. 1997 Sep;226(3):271-6; discussion 276-8.

ReferenceCitation: McMasters KM, Tuttle TM, Carlson DJ, Brown CM, Noyes RD, Glaser RL, Vennekotter DJ, Turk PS, Tate PS, Sardi A, Cerrito PB, Edwards MJ. Sentinel lymph node biopsy for breast cancer: a suitable alternative to routine axillary dissection in multi-institutional practice when optimal technique is used. J Clin Oncol. 2000 Jul;18(13):2560-6.

ReferenceCitation: Weaver DL, Krag DN, Ashikaga T, Harlow SP, O'Connell M. Pathologic analysis of sentinel and nonsentinel lymph nodes in breast carcinoma: a multicenter study. Cancer. 2000 Mar 1;88(5):1099-107.

ReferenceCitation: Tafra L, McMasters KM, Whitworth P, Edwards MJ. Credentialing issues with sentinel lymph node staging for breast cancer. Am J Surg. 2000 Oct;180(4):268-73.

ReferenceCitation: McMasters KM, Wong SL, Chao C, Woo C, Tuttle TM, Noyes RD, Carlson DJ, Laidley AL, McGlothin TQ, Ley PB, Brown CM, Glaser RL, Pennington RE, Turk PS, Simpson D, Edwards MJ; University of Louisville Breast Cancer Study Group. Defining the optimal surgeon experience for breast cancer sentinel lymph node biopsy: a model for implementation of new surgical techniques. Ann Surg. 2001 Sep;234(3):292-9; discussion 299-300.

ReferenceCitation: Orr RK, Hoehn JL, Col NF. The learning curve for sentinel node biopsy in breast cancer: practical considerations. Arch Surg. 1999 Jul;134(7):764-7. Review.

ReferenceCitation: Bedrosian I, Reynolds C, Mick R, Callans LS, Grant CS, Donohue JH, Farley DR, Heller R, Conant E, Orel SG, Lawton T, Fraker DL, Czerniecki BJ. Accuracy of sentinel lymph node biopsy in patients with large primary breast tumors. Cancer. 2000 Jun 1;88(11):2540-5.

ReferenceCitation: Chung MH, Ye W, Giuliano AE. Role for sentinel lymph node dissection in the management of large (> or = 5 cm) invasive breast cancer. Ann Surg Oncol. 2001 Oct;8(9):688-92.

ReferenceCitation: Lelievre L, Houvenaeghel G, Buttarelli M, Brenot-Rossi I, Huiart L, Tallet A, Tarpin C, Jacquemier J. Value of the sentinel lymph node procedure in patients with large size breast cancer. Ann Surg Oncol. 2007 Feb;14(2):621-6. Epub 2006 Nov 12.

ReferenceCitation: Schwartz GF, Giuliano AE, Veronesi U; Consensus Conference Committee. Proceedings of the consensus conference on the role of sentinel lymph node biopsy in carcinoma of the breast, April 19-22, 2001, Philadelphia, Pennsylvania. Cancer. 2002 May 15;94(10):2542-51. Review.

ReferenceCitation: Lyman GH, Giuliano AE, Somerfield MR, Benson AB 3rd, Bodurka DC, Burstein HJ, Cochran AJ, Cody HS 3rd, Edge SB, Galper S, Hayman JA, Kim TY, Perkins CL, Podoloff DA, Sivasubramaniam VH, Turner RR, Wahl R, Weaver DL, Wolff AC, Winer EP; American Society of Clinical Oncology. American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. J Clin Oncol. 2005 Oct 20;23(30):7703-20. Epub 2005 Sep 12.

ReferenceCitation: Edwards M, Giuliano A, Reintgen D, Tafra L. Consensus statement on guidelines for performance of sentinel lymph node biopsy for breast cancer. Am Soc Breast Surg Q. Press Release, 1998 ;Fall :3

lead_sponsor: Centre Leon Berard

location_facility:
Clinique des 2 Caps
Clinique des Acacias
Centre Oscar Lambret
Hôtel Dieu
CH Calais
Centre Léon Bérard
CMCO
Centre Hospitalier Lyon Sud
Clinique Pasteur
Institut Bergonié
Centre René Gauducheau
Centre René Huguenin
CH Boulogne sur Mer
Centre Val d'Aurelle
Centre Alexis Vautrin
CH Arrondissement Montreuil sur Mer
Institut Paoli Calmettes
CHRU Saint Etienne
Institut Claudius Régaud
Centre Paul Papin
Centre Henri Becquerel
Centre Eugène Marquis

intervention_type: Other

lead_sponsor_type: academique


title: Randomized Multicenter Phase III Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas: Gemcitabine With or Without Chemoradiotherapy and With or Without Erlotinib. Intergroup Study

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer.

PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

ReferenceCitation: Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouché O, Shannon J, André T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Centre Hospitalier Universitaire de Bicetre

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: Centre Radiotherapie Oncologie Moyenne Garonne

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


title: A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease

summary: This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

ReferenceCitation: Morgan JC, Dhall R, Rubens R, Khanna S, Gupta S. Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations. Parkinsons Dis. 2018 Oct 22;2018:9763057. doi: 10.1155/2018/9763057. eCollection 2018.

ReferenceCitation: Hauser RA, Hsu A, Kell S, Espay AJ, Sethi K, Stacy M, Ondo W, O'Connell M, Gupta S; IPX066 ADVANCE-PD investigators. Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations: a phase 3 randomised, double-blind trial. Lancet Neurol. 2013 Apr;12(4):346-56. doi: 10.1016/S1474-4422(13)70025-5. Epub 2013 Feb 26.

lead_sponsor: Impax Laboratories, LLC

location_country:
Poland
Spain
Canada
Ukraine
United States
France
Romania
Germany

location_facility:
Investigator 43
Investigator 21
Investigator 8
Investigator 7
Investigator 24
Investigator 62
Investigator 16
Investigator 15
Investigator 3
Investigator 42
Investigator 52
Investigator 46
Investigator 9
Investigator 17
Investigator 61
Investigator 20
Investigator 14
Investigator 58
Investigator 72
Investigator 67
Investigator 34
Investigator 11
Investigator 71
Investigator 48
Investigator 23
Investigator 38
Investigator 33
Investigator 12
Investigator 13
Investigator 25
Investigator 32
Investigator 47
Investigator 66
Investigator 50
Investigator 18
Investigator 35
Investigator 68
Investigator 10
Investigator 64
Investigator 63
Investigator 55
Investigator 44
Investigator 1
Investigator 29
Investigator 69
Investigator 27
Investigator 39
Investigator 57
Investigator 60
Investigator 26
Investigator 31
Investigator 49
Investigator 30
Investigator 28
Investigator 40
Investigator 41
Investigator 36
Investigator 59
Investigator 45
Investigator 19
Investigator 22
Investigator 70
Investigator 51
Investigator 5
Investigator 53
Investigator 65
Investigator 54
Investigator 56
Investigator 2
Investigator 4
Investigator 6
Investigator 37


title: Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients With Chronic Failure of Intensive Insulin Therapy and Conventional Care. The TELEDIAB-1 STUDY

summary:
TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care.

Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months

ReferenceCitation: Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility: Centre Hospitalier de Belfort Montbéliard

intervention_type: Device


title: Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with metastatic colorectal cancer.

ReferenceCitation: Manfredi S, Bouché O, Rougier P, Dahan L, Loriot MA, Aparicio T, Etienne PL, Lafargue JP, Lécaille C, Legoux JL, Le Malicot K, Maillard E, Lecomte T, Khemissa F, Breysacher G, Michel P, Mitry E, Bedenne L. High-Dose FOLFIRI plus Bevacizumab in the Treatment of Metastatic Colorectal Cancer Patients with Two Different UGT1A1 Genotypes: FFCD 0504 Study. Mol Cancer Ther. 2015 Dec;14(12):2782-8. doi: 10.1158/1535-7163.MCT-15-0293. Epub 2015 Oct 22.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier de Chalons-en-Champagne

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier General Lucien Hussel


title: Open Label, Randomized, Multicenter Phase II Study of a Combination of Torisel® (Temsirolimus) and Avastin® (Bevacizumab) Versus Sutent® (Sunitinib) and Versus a Combination of Avastin® (Bevacizumab) and Roféron® (Interferon Alpha-2a) in First-line Treatment of Patients With Metastatic Renal Cell Carcinoma.

acronym: TORAVA

summary:
The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a combination of Torisel® and Avastin® given at first-line treatment in patients with metastatic renal cancer.

Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®, or Sutent® or IFN+Avastin®.

ReferenceCitation: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203.

ReferenceCitation: Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24.

ReferenceCitation: Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81.

ReferenceCitation: Négrier S, Gravis G, Pérol D, Chevreau C, Delva R, Bay JO, Blanc E, Ferlay C, Geoffrois L, Rolland F, Legouffe E, Sevin E, Laguerre B, Escudier B. Temsirolimus and bevacizumab, or sunitinib, or interferon alfa and bevacizumab for patients with advanced renal cell carcinoma (TORAVA): a randomised phase 2 trial. Lancet Oncol. 2011 Jul;12(7):673-80. doi: 10.1016/S1470-2045(11)70124-3. Epub 2011 Jun 12.

ReferenceCitation: Polena H, Creuzet J, Dufies M, Sidibé A, Khalil-Mgharbel A, Salomon A, Deroux A, Quesada JL, Roelants C, Filhol O, Cochet C, Blanc E, Ferlay-Segura C, Borchiellini D, Ferrero JM, Escudier B, Négrier S, Pages G, Vilgrain I. The tyrosine-kinase inhibitor sunitinib targets vascular endothelial (VE)-cadherin: a marker of response to antitumoural treatment in metastatic renal cell carcinoma. Br J Cancer. 2018 May;118(9):1179-1188. doi: 10.1038/s41416-018-0054-5. Epub 2018 Mar 22.

location_facility: Centre Hospilier Universitaire de Poitiers

location_facility: Clinique Valdegour-Centre médical Oncogard

location_facility: Centre Hospitalier Universitaire de Lille - Hôpital Claude Huriez

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hôpital St André

location_facility: Centre Hospitalier Universitaire DUPUTRYEN

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universiariare Lyon, Hôpital Lyon Sud


title: Pharmaco-epidemiological Description of the Patient Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

summary: To obtain information on clinical practices for patients treated by Aptivus in real life

study_type: Observational

time_perspective: Prospective

lead_sponsor: Boehringer Ingelheim

location_facility: 1182.127.3301 Boehringer Ingelheim Investigational Site


title: A Randomised, Multicentre, Single-Blind, Phase IV Study, of the Efficacy, Safety, and Acceptability of Moviprep® Versus Colopeg® in Colonoscopy Preparation.

acronym: NORMO

summary:
Primary:

- To demonstrate the superiority of Moviprep® versus Colopeg® in gut cleansing prior to colonoscopy.

Secondary:

To assess the safety of Moviprep® versus Colopeg®.
To assess acceptability of Moviprep® versus Colopeg®.

ReferenceCitation: Bitoun A, Ponchon T, Barthet M, Coffin B, Dugué C, Halphen M; Norcol Group. Results of a prospective randomised multicentre controlled trial comparing a new 2-L ascorbic acid plus polyethylene glycol and electrolyte solution vs. sodium phosphate solution in patients undergoing elective colonoscopy. Aliment Pharmacol Ther. 2006 Dec;24(11-12):1631-42. Epub 2006 Nov 10.

lead_sponsor: Norgine

location_facility: Service des Maladies de l'Appareil Digestif, Centre Hospitalier Régional et Universitaire

location_facility: Service de Gastroentérologie, HOPITAL DE L'ARCHET

location_facility: Service de Gastroentérologie du Pr. MARTEAU, HÔPITAL LARIBOISIERE

location_facility: Service de Gastro-Entérologie, HOPITAL TROUSSEAU CHRU de Tours

location_facility: Service de Gastroentérologie du Dr. Chousterman, HOPITAL INTERCOMMUNAL

location_facility: Service de Gastroentérologie,CENTRE HOSPITALIER d'AVIGNON

location_facility: Service d'Hépato-Gastroentérologie, CHRU NANCY, HOPITAL DE BRABOIS

location_facility: Service de Gastro-Entérologie, HÔPITAL GEORGES POMPIDOU

location_facility: Service de Gastroentérologie du Pr. LEREBOURS, HOPITAL CHARLES NICOLLE

location_facility: Centre Des Maladies Du Foie Et de L'Appareil Digestif


acronym: DECAPUB

title: Phase III, Multicentre, Non-comparative, Open and Single Stage Study to Assess the Efficacy and Safety of Pamoate of Triptorelin 11.25 MG in Children With Precocious Puberty

lead_sponsor: Ipsen

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

location_facility:
Hôpital Necker - Enfants Malades
Hôpital Debrousse
Hôpital Saint-Jacques
Hôpital Jeanne de Flandre
Hôpital de la Gespe
Hôpital des Enfants
Hôpital St-Vincent de Paul
Hôpital Hotel-Dieu (CHU)
Hôpital Charles Nicolle
Medical Centre
Hôpital Trousseau
Hôpital Robert Debré
American Memorial Hospital
Hôpital Flaubert
Hôpital de la Timone Enfants
Hôpital du Bocage
Hôpital Archet 2
Hôpital Hautepierre

summary: The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.


title: An Open Label Study to Evaluate the Safety of NeoRecormon in the Treatment of Anemia in Patients With Chronic Hepatitis C Who Are Treated With Pegylated Interferon + Ribavirin Combination Therapy

summary: This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


title: A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR

summary:
The objectives of this trial conducted in early Parkinson's disease (PD) patients are:

To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal;
To establish if this successful switch can be obtained with or without dose-adaptation;
To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.

location_country: Germany France Netherlands

location_facility: 248.636.3308B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3306B Boehringer Ingelheim Investigational Site

location_facility: 248.636.49004 Boehringer Ingelheim Investigational Site

location_facility: 248.636.49008 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3301A Boehringer Ingelheim Investigational Site

location_facility: 248.636.31003 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3305B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3313A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3302B Boehringer Ingelheim Investigational Site

location_facility: 248.636.49003 Boehringer Ingelheim Investigational Site

location_facility: 248.636.31005 Boehringer Ingelheim Investigational Site

location_facility: 248.636.49007 Boehringer Ingelheim Investigational Site

location_facility: 248.636.49002 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3303A Boehringer Ingelheim Investigational Site

location_facility: 248.636.31001 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3302A Boehringer Ingelheim Investigational Site

location_facility: 248.636.49006 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3304A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3312B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3309B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3301B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3311A Boehringer Ingelheim Investigational Site

location_facility: 248.636.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3308E Boehringer Ingelheim Investigational Site

location_facility: 248.636.31006 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3301D Boehringer Ingelheim Investigational Site

location_facility: 248.636.3305A Boehringer Ingelheim Investigational Site

location_facility: 248.636.3308C Boehringer Ingelheim Investigational Site

location_facility: 248.636.49001 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3303B Boehringer Ingelheim Investigational Site

location_facility: 248.636.3307C Boehringer Ingelheim Investigational Site

location_facility: 248.636.31002 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3303C Boehringer Ingelheim Investigational Site

location_facility: 248.636.3312A Boehringer Ingelheim Investigational Site

location_facility: 248.636.31004 Boehringer Ingelheim Investigational Site

location_facility: 248.636.3308D Boehringer Ingelheim Investigational Site


acronym: PROPICE

title: Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux,in Venous Thromboembolic Events Prevention in Patients With Renal Impairment and Undergoing a Major Orthopaedic Surgery. PROPICE Study

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
COUVRET Claude
CHAMBON Françoise
TISSIER Dominique
CHEVALEREAUD Erick
RIPART Jacques
GARANGER Thierry
BONNEMAISON Julie
PEGOIX Michel
MARTIN
SZTARCK François
MAZUIRE Elisabeth
BEGOU Gérard
BARRE Jeanne
LIGNOT Sophie
CAPDEVILLA Xavier
GAERTNER Elisabeth
THERY Philippe
LETOURNEAU Bernard
FUZIER Régis
LANGERON Olivier
LEMANISSIER Denis
SCHOEFFLER Pierre
DUVERGER Daniel
BAYLOT Denis
RABUEL Christophe
PERON Alain
CHARRET Françoise
AUSSET Sylvain
BELLOUCIF Sadek

summary:
Fondaparinux is an antithrombotic agent having already received a regulatory approval by the European Authorities in venous thromboembolic event prevention after major orthopaedic surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The bleeding risk associated with this prescription is highly related to renal function evaluated by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of 2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated pharmakinetic data without any support of clinical data.

prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5 mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl between 20 and 30 ml/min and undergoing a major orthopaedic surgery.


title: Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease

acronym: RAPID

summary: Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.

ReferenceCitation: Beaugerie L, Seksik P, Nion-Larmurier I, Gendre JP, Cosnes J. Predictors of Crohn's disease. Gastroenterology. 2006 Mar;130(3):650-6.

ReferenceCitation: Cosnes J, Nion-Larmurier I, Beaugerie L, Afchain P, Tiret E, Gendre JP. Impact of the increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery. Gut. 2005 Feb;54(2):237-41. Erratum in: Gut. 2005 May;54(5):734.

ReferenceCitation: Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Hopital Bichat
Hopital St Antoine
Hopital Lariboisiere
CHU LYON
CHU NICE
Chu Clermont-Ferrand
Hopital Saint Louis
Chu Amiens
Chu Strasbourg
Hopital Haut Leveque
Chu Reims
CHU CAEN
Chu Nantes
Hopital Louis Mourrier
Chu Besancon
Chu Marseille - Hopital Nord
Chru Lille
Hopital Georges Pompidou
Chu Toulouse
Hopital Bicetre
Ch Le Raincy Montfermeil
Hopital Cochin
Hopital Beaujon
Chu Rouen
Chu Tours
Institut Mutualiste Montsouris (Imm)


title: A Randomized, Open-label Study to Investigate the Impact of Bone Marker Feedback on Persistence to Once Monthly Oral Bonviva (Ibandronate) Treatment for Post-menopausal Osteoporosis.

summary: This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

ReferenceCitation: Roux C, Giraudeau B, Rouanet S, Dubourg G, Perrodeau E, Ravaud P. Monitoring of bone turnover markers does not improve persistence with ibandronate treatment. Joint Bone Spine. 2012 Jul;79(4):389-92. doi: 10.1016/j.jbspin.2011.05.001. Epub 2011 Jun 23.


title: Phase II of Sunitinib (SUTENT®) in First Line for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma - SUPAP

summary:
RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works as first-line therapy in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.

ReferenceCitation: Cabarrou B, Boher JM, Bogart E, Tresch-Bruneel E, Penel N, Ravaud A, Escudier B, Mahier Ait-Oukhatar C, Delord JP, Roché H, Filleron T. How to report toxicity associated with targeted therapies? Ann Oncol. 2016 Aug;27(8):1633-8. doi: 10.1093/annonc/mdw218. Epub 2016 May 23.

ReferenceCitation: Ravaud A, Oudard S, De Fromont M, Chevreau C, Gravis G, Zanetta S, Theodore C, Jimenez M, Sevin E, Laguerre B, Rolland F, Ouali M, Culine S, Escudier B. First-line treatment with sunitinib for type 1 and type 2 locally advanced or metastatic papillary renal cell carcinoma: a phase II study (SUPAP) by the French Genitourinary Group (GETUG)†. Ann Oncol. 2015 Jun;26(6):1123-1128. doi: 10.1093/annonc/mdv149. Epub 2015 Mar 23.

lead_sponsor: UNICANCER

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz


status: Terminated

title: Comparison of 2 Chemotherapy Regimens in Non-small-cell Lung Cancer (NSCLC) Patients Relapsing After Surgery and Peri-operative Chemotherapy. A Randomized Phase III Study.

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

location_facility: Hôpitaux du Léman - Pneumologie et Maladies Infectieuruses

location_facility: APHP - CHU Avicenne - Oncologie Medicale

location_facility: Chambray Les Tours - Clinique Léonard de Vinci

summary: Relapses after perioperative chemotherapy and surgery

status_simplified: Unknown


title: Study of Positron Emission Tomography With 3'-Deoxy-3'-[18F] Fluoro-thymidine ([18F]-FLT) for the Evaluation of Response to Neoadjuvant Chemotherapy for Cancers of the Breast

summary:
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer.

PURPOSE: This clinical trial is studying how well positron emission tomography using 3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy.

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc


title: A Randomized, Open Label Study to Evaluate the Effect of Doxycycline on Tarceva-induced Skin Rash in Patients With Non-small Cell Lung Cancer After Failure of First Line Chemotherapy

summary: This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.


type: Other Grant/Funding Number

title: Specific Care and Assistance Plan for Alzheimer's Disease: Impact Study on Disease Progression and Management Modalities

acronym: PLASA

summary:
The main objective of this work is to assess the feasibility and efficacy of a specific Care and Assistance Plan for Alzheimer's disease (PLASA). The main outcome measure selected is incapacity in carrying out the basic activities of daily living, evaluated by the ADCS-ADL scale .

The PLASA was developed by a working group appointed by the Direction Générale de la Santé as part of the government programme of action on Alzheimer's disease (October 2001, Ministère de l'Emploi et de la Solidarité).

primary_purpose: Supportive Care

ReferenceCitation: Callahan CM, Boustani MA, Unverzagt FW, Austrom MG, Damush TM, Perkins AJ, Fultz BA, Hui SL, Counsell SR, Hendrie HC. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006 May 10;295(18):2148-57.

ReferenceCitation: Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22.

ReferenceCitation: Teri L, Logsdon RG, McCurry SM. Nonpharmacologic treatment of behavioral disturbance in dementia. Med Clin North Am. 2002 May;86(3):641-56, viii. Review.

ReferenceCitation: Vickrey BG, Mittman BS, Connor KI, Pearson ML, Della Penna RD, Ganiats TG, Demonte RW Jr, Chodosh J, Cui X, Vassar S, Duan N, Lee M. The effect of a disease management intervention on quality and outcomes of dementia care: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):713-26.

ReferenceCitation: Nourhashemi F, Andrieu S, Gillette-Guyonnet S, Giraudeau B, Cantet C, Coley N, Vellas B; PLASA Group. Effectiveness of a specific care plan in patients with Alzheimer's disease: cluster randomised trial (PLASA study). BMJ. 2010 Jun 3;340:c2466. doi: 10.1136/bmj.c2466.

ReferenceCitation: Nourhashemi F, Gillette-Guyonnet S, Andrieu S, Rolland Y, Ousset PJ, Vellas B; PLASA group. A randomized trial of the impact of a specific care plan in 1120 Alzheimer's patients (PLASA Study) over a two-year period: design and baseline data. J Nutr Health Aging. 2008 Apr;12(4):263-71.

lead_sponsor: University Hospital, Toulouse

location_facility: University Hospital BROCA - La Rochefoucauld

location_facility: University Hospital, Hôpital Xavier Arnozan

location_facility: Hospital Center Notre Dame du Bon Secours


acronym: CRYSTMAS

title: Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis

lead_sponsor: Fresenius Kabi

ReferenceCitation: Guidet B, Martinet O, Boulain T, Philippart F, Poussel JF, Maizel J, Forceville X, Feissel M, Hasselmann M, Heininger A, Van Aken H. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: the CRYSTMAS study. Crit Care. 2012 May 24;16(3):R94. doi: 10.1186/cc11358.

location_country: Germany France

location_facility: CH Sud Francilien, Site Gilles de Corbeil, Réanimation Polyvalente

location_facility: Hôpital Lapeyronie / CHU Montpellier, Département d'Anesthésie Réanimation

location_facility: Hôpital St Louis, Département Anesthésie et Réanimation Chirurgicale

location_facility: CHU Nîmes, Service de Réanimation, Division Anesthésie-Réa Douleur Urgence, Groupe Hospitalo-Universitaire Caremeau,

location_facility: Klinik und Poliklinik für Anästhesiologie und Intensivtherapie - Universitätsklinikum Leipzig AöR

location_facility: Centre Hospitalier de Metz, Réa Polyvalente

location_facility: Centre Hospitalier Fleyriat, Service de Réanimation Polyvalente

location_facility: Centre Hospitalier d'Avignon, Service de Réanimation Polyvalente

location_facility: Hôpital Civil de Strasbourg, Service de Réanimation Médicale

location_facility: Hôpital Central, Service Anesthésie-Réanimation, Chirurgicale CHU

location_facility: Klinik und Poliklinik für Anästhesiologie und operative Intensivmedizin der Westf. Wilhelms-Universität

location_facility: CHU de Bicêtre, Dpt d'Anesthésie Réanimation Chir.

location_facility: CH Manchester, Service de Réanimation Polyvalente

location_facility: CHU de Dijon - Hôpital du Bocage Service de Réanimation Médicale

location_facility: Hôpital St Antoine, Réanimation Médicale

location_facility: CHI Poissy - St Germain en Laye, Site de St Germain en Laye

location_facility: Hôpital Avicenne, Service de Réanimation

location_facility: Hôpital Saint-Joseph, Service de Réanimation Polyvalente

location_facility: Universitätsklinikum Tübingen, Klinik für Anästhesiologie und Intensivmedizin

location_facility: Hôpital Sud, Unité de Réanimation Médicale

location_facility: Hôpital de la Source, Réanimation Polyvalente

location_facility: Centre Hospitalier de Belfort-Montbéliard, Service de Réanimation et Maladies Infectieuses, Site de Belfort

summary: The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.


acronym: IASIS

title: A Randomized Blinded, Placebo-Controlled, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the Investigational eFlow® Inline System in Mechanically Ventilated Patients With Gram-negative Bacterial Pneumonia (IASIS)

lead_sponsor: Cardeas Pharma

ReferenceCitation: Kollef MH, Ricard JD, Roux D, Francois B, Ischaki E, Rozgonyi Z, Boulain T, Ivanyi Z, János G, Garot D, Koura F, Zakynthinos E, Dimopoulos G, Torres A, Danker W, Montgomery AB. A Randomized Trial of the Amikacin Fosfomycin Inhalation System for the Adjunctive Therapy of Gram-Negative Ventilator-Associated Pneumonia: IASIS Trial. Chest. 2017 Jun;151(6):1239-1246. doi: 10.1016/j.chest.2016.11.026. Epub 2016 Nov 24.

location_country:
Spain
Greece
Hungary
Puerto Rico
United States
France
Turkey

summary: To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.


title: Thalidomide for the Treatment of Cytopenias of Patients With Low Risk Myelodysplastic Syndromes

summary:
The GFM previously conducted a dose-escalating phase II trial of thalidomide in MDS with a minimum dose of 200mg/d and a maximum dose 800mg/d. Responses were evaluated according to IWG criteria at week 16 and thalidomide continued up to week 56 in responders. 82% patients received at least 8 weeks of treatment and were evaluable. 59% had hematological improvement, mainly on the erythroid lineage (Increase of Hemoglobin). Most responses were observed at low doses and between 4 and 8 weeks.

The objectives of this trial (Thal-SMD-20) are to evaluate the efficacy and tolerance of lower doses thalidomide in low risk MDS patients with transfusion-dependant anemia.

ReferenceCitation: Bouscary D, Legros L, Tulliez M, Dubois S, Mahe B, Beyne-Rauzy O, Quarre MC, Vassilief D, Varet B, Aouba A, Gardembas M, Giraudier S, Guerci A, Rousselot P, Gaillard F, Moreau A, Rousselet MC, Ifrah N, Fenaux P, Dreyfus F; Groupe Français des Myélodysplasies (GFM). A non-randomised dose-escalating phase II study of thalidomide for the treatment of patients with low-risk myelodysplastic syndromes: the Thal-SMD-2000 trial of the Groupe Français des Myélodysplasies. Br J Haematol. 2005 Dec;131(5):609-18.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
CHU Purpan
CHU Nancy-Brabois
Hopital Cochin
CHU de Nantes
Institut Paoli Calmette
Hopital Avicenne
CHU Albert Michallon
CH d'Avignon
CHU d'Angers
CH de la Cote Basque
Hopital Saint Antoine
CHRU de Lille - Hopital C. Huriez
CHU de Nice - Hopital de l'Archet 1
Hotel Dieu
Hopital Necker
Centre Henry Becquerel
CHU de Limoges
CHU de Brest - Hopital Morvan
CHU Dijon
CH Joffre


title: Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.

acronym: ECHODIAH

summary:
We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to:

evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis
to investigate the potential structure-modifying effect of diacerein in patients with hip osteoarthritis

This study compare also after ten years the percentage of patients in each treatment group who require a hip replacement surgery

ReferenceCitation: Dougados M, Nguyen M, Berdah L, Maziéres B, Vignon E, Lequesne M; ECHODIAH Investigators Study Group. Evaluation of the structure-modifying effects of diacerein in hip osteoarthritis: ECHODIAH, a three-year, placebo-controlled trial. Evaluation of the Chondromodulating Effect of Diacerein in OA of the Hip. Arthritis Rheum. 2001 Nov;44(11):2539-47.

lead_sponsor: Laboratoires NEGMA

location_facility: Hôpital Cochin, clinique de rhumatologie