title: A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis

acronym: UC

summary: The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in participants with active Ulcerative Colitis (UC).

ReferenceCitation: Danese S, Neurath MF, Kopoń A, Zakko SF, Simmons TC, Fogel R, Siegel CA, Panaccione R, Zhan X, Usiskin K, Chitkara D. Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2526-2534.e9. doi: 10.1016/j.cgh.2019.12.032. Epub 2020 Jan 8.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Poland
Italy
Russian Federation
Australia
Netherlands
Canada
New Zealand
Ukraine
Hungary
United States
France
Germany
Bulgaria
Czechia

location_facility: Lviv Emergency Clinical Hospital, Therapeutics Department No. 1

location_facility: Digestive Research Center/ Gastroenterology Consultants of San Antonio

location_facility: Digestive Health Specialists of The Southeast

location_facility: Private Enterprise Private Manufacture Company Acinus

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Kremenchuk City Hospital # 1 n.a O.T.Bohaievskyi

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Consultants for Clinical Research of South Florida

location_facility: Multiprofile Hospital for Active Treatment Kaspela

location_facility: IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Osrodek Badan Klinicznych CLINSANTE S.C.

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Vinnytsia Regional Clinical Hospital n a M I Pyrohov

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Regional Clinical Hospital, Gastroenterology department, State Higher Education Institute Ivano-Frankivsk National Medical University

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

location_facility: SEIHPE Rostov State Medical University of MoH of RF

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: Multiprofile Hospital for Active Treatment Sveta Marina EAD

location_facility: Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi

location_facility: Medical Center Asklepion - Humane Medicine Research EOOD

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: University of Iowa Hospitals and Clinics

location_facility: Russian Medical Military Academy na SMKirov

location_facility: Connecticut Clinical Research Foundation

location_facility: Southern California Research Institute Medical Group, Inc.

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

location_facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Spec. Gabinety Lekarskie

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Municipal Institution Odesa Regional Clinical Hospital


type: EudraCT Number

title: A Phase II Randomized, Double-Blind Study of Neoadjuvant Letrozole Plus GDC-0032 Versus Letrozole Plus Placebo in Postmenopausal Women With ER-positive/HER2-negative, Early Stage Breast Cancer

summary: This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Eiger D, Brandão M, de Azambuja E. Lessons learned at SABCS 2019 and to-dos from immunotherapy in breast cancer. ESMO Open. 2020 Mar;5(2). pii: e000688. doi: 10.1136/esmoopen-2020-000688.

ReferenceCitation: Eiger D, Franzoi MA, Pondé N, Brandão M, de Angelis C, Schmitt Nogueira M, de Hemptinne Q, de Azambuja E. Cardiotoxicity of trastuzumab given for 12 months compared to shorter treatment periods: a systematic review and meta-analysis of six clinical trials. ESMO Open. 2020 Feb;5(1). pii: e000659. doi: 10.1136/esmoopen-2019-000659.

ReferenceCitation: Saura C, Hlauschek D, Oliveira M, Zardavas D, Jallitsch-Halper A, de la Peña L, Nuciforo P, Ballestrero A, Dubsky P, Lombard JM, Vuylsteke P, Castaneda CA, Colleoni M, Santos Borges G, Ciruelos E, Fornier M, Boer K, Bardia A, Wilson TR, Stout TJ, Hsu JY, Shi Y, Piccart M, Gnant M, Baselga J, de Azambuja E. Neoadjuvant letrozole plus taselisib versus letrozole plus placebo in postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2019 Sep;20(9):1226-1238. doi: 10.1016/S1470-2045(19)30334-1. Epub 2019 Aug 8.

lead_sponsor: Genentech, Inc.

location_country:
Spain
Italy
United Kingdom
El Salvador
United States
Peru
Belgium
Czechia
Poland
Portugal
Austria
Australia
Panama
Mexico
Brazil
Switzerland
Guatemala
Hungary
Germany
Korea, Republic of
France
Chile

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Ordensklinikum Linz Barmherzige Schwestern ; Abt. f. Allgemein- und Viszeralchirurgie

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: Memorial Sloan-Kettering Cancer Center; Hematology/Oncology

location_facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Centre Jean Perrin; Division De Recherche Clinique

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon

location_facility: Royal Bournemouth General Hospital; Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Chirurgie - Abt. für Allgemeinchirurgie

location_facility: Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie

location_facility: Instituto Universitario Dexeus; Servicio de Oncología

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Centre Rene Huguenin; ONCOLOGIE GENETIQUE

location_facility: Newcastle Mater Misericordiae Hospital; Oncology

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: Marien-Hospital Witten; Frauenklinik Brustzentrum

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Oddział Chemioterapii

location_facility: Klinikum Kreuzschwestern Wels; Iii. Interne Abt.

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

location_facility: National Cancer Center; Medical Oncology

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Frimley Park Hospital; Breast Resaerch Team

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Hospital Clinico Universitario; Oncologia

location_facility: Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico

location_facility: Hospital Nacional Cayetano Heredia; Hematology - Oncology

location_facility: Ospedale Per Acuti Mater Salutis Di Legnago

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Hopital Saint Louis; Service Onco Thoracique

location_facility: Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hospital Universitario de Fuenlabrada; Servicio de Oncologia

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

location_facility: Centro Clinico Champalimaud; Oncologia Medica

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


ipd_sharing: Yes

intervention_type: Biological

title: An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A

lead_sponsor: Bioverativ, a Sanofi company

source: euctr

ReferenceCitation: Königs C, Ozelo MC, Dunn A, Kulkarni R, Nolan B, Brown SA, Schiavulli M, Gunawardena S, Mukhopadhyay S, Jayawardene D, Winding B, Carcao M. First study of extended half-life rFVIIIFc in previously untreated patients with hemophilia A: PUPs A-LONG final results. Blood. 2022 Jun 30;139(26):3699-3707. doi: 10.1182/blood.2021013563.

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, blank 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 trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Poland
Brazil
Spain
Ireland
Italy
Australia
Netherlands
Canada
New Zealand
United Kingdom
Sweden
United States
France
Germany

summary: The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.


title: A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients With Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial

acronym: EBBINGHAUS

summary: This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Giugliano RP, Mach F, Zavitz K, Kurtz C, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Design and rationale of the EBBINGHAUS trial: A phase 3, double-blind, placebo-controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid-lowering therapy-A cognitive study of patients enrolled in the FOURIER trial. Clin Cardiol. 2017 Feb;40(2):59-65. doi: 10.1002/clc.22678. Epub 2017 Feb 16.

ReferenceCitation: Giugliano RP, Mach F, Zavitz K, Kurtz C, Im K, Kanevsky E, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Robinson JG, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Cognitive Function in a Randomized Trial of Evolocumab. N Engl J Med. 2017 Aug 17;377(7):633-643. doi: 10.1056/NEJMoa1701131.

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
South Africa
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Turkey
Norway
Malaysia
Sweden
Slovakia
Canada
Hungary
Germany
Denmark
Greece
Latvia
Estonia
New Zealand
Finland
France
Netherlands


title: Safety and Immunogenicity Study of GSK Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK23211381A) Manufactured With a New Process in Adults and Children

summary: The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process [IP]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process [LP]).

primary_purpose: Prevention

ReferenceCitation: Claeys C, Drame M, García-Sicilia J, Zaman K, Carmona A, Tran PM, Miranda M, Martinón-Torres F, Thollot F, Horn M, Schwarz TF, Behre U, Merino JM, Sadowska-Krawczenko I, Szymański H, Schu P, Neumeier E, Li P, Jain VK, Innis BL. Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults. BMC Infect Dis. 2018 Apr 18;18(1):186. doi: 10.1186/s12879-018-3079-8.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Spain
Bangladesh
France
United States
Germany
Czechia


intervention_type: Drug

title: A Phase II, Open-Label Study Evaluating the Safety and Efficacy of GDC-0199 (ABT-199) Plus Bendamustine Plus Rituximab (BR) in Comparison With BR Alone or GDC-0199 Plus Rituximab (R) in Patients With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Zinzani PL, Flinn IW, Yuen SLS, Topp MS, Rusconi C, Fleury I, Le Dû K, Arthur C, Pro B, Gritti G, Crump M, Petrich A, Samineni D, Sinha A, Punnoose EA, Szafer-Glusman E, Spielewoy N, Mobasher M, Humphrey K, Kornacker M, Hiddemann W. Venetoclax-rituximab with or without bendamustine vs bendamustine-rituximab in relapsed/refractory follicular lymphoma. Blood. 2020 Dec 3;136(23):2628-2637. doi: 10.1182/blood.2020005588.

location_country:
United Kingdom
Italy
Australia
Canada
United States
France
Belgium
Germany

location_facility: Irccs Policlinico San Matteo; Divisione Di Ematologia

location_facility: Universitätsklinikum Jena; Klinik für Innere Medizin II

location_facility: University College London, Department of Haematology

location_facility: UCLA School of Medicine; Hematology/Oncology

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Universitätsklinikum Köln; Klinik I für Innere Medizin

location_facility: Royal Marsden Nhs Trust; Consultant Cancer Physician

location_facility: Chum Hopital Notre Dame; Centre D'Oncologie

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Royal Prince Alfred Hospital; Medical Oncology

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: University of Illinois at Chicago College of Medicine

location_facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Primary Healthcare Associates SC - Harvey

location_facility: University of Pennsylvania; School of Medicine

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Az. Osp. Di Careggi; Divisione Di Ematologia

location_facility: Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

location_facility: Klinikum Chemnitz gGmbH; Klinik f. Innere Medizin III

location_facility: West Virginia Uni Med. Center - Robert Byrd Health Science

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie

location_facility: University of Kansas; Medical Center & Medical pavilion

summary: This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.


title: A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors

summary:
Primary Objectives:

To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W).
To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle).
To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1.

Secondary Objectives:

To characterize the overall safety profile of SAR408701.
To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives.
To identify the recommended phase 2 dose (RP2D) of SAR408701.
To assess the potential immunogenicity of SAR408701.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

lead_sponsor: Sanofi

location_country:
Spain
Canada
Korea, Republic of
United States
France

location_facility:
Investigational Site Number 250003
Investigational Site Number 840001
Investigational Site Number 840006
Investigational Site Number 410005
Investigational Site Number 410002
Investigational Site Number 410001
Investigational Site Number 250002
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 250001
Investigational Site Number 410004
Investigational Site Number 724001
Investigational Site Number 724006
Investigational Site Number 724003
Investigational Site Number 124001
Investigational Site Number 840002
Investigational Site Number 410003
Investigational Site Number 250007
Investigational Site Number 724004
Investigational Site Number 840005
Investigational Site Number 840003
Investigational Site Number 250004
Investigational Site Number 840105
Investigational Site Number 724007
Investigational Site Number 250005

status_simplified: Ongoing


type: Other Identifier

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Pyridorin (Pyridoxamine Dihydrochloride) in Subjects With Nephropathy Due to Type 2 Diabetes (PIONEER)

acronym: PIONEER

summary: The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.

status: Terminated

lead_sponsor: NephroGenex, Inc.

location_country:
Poland
Hong Kong
Spain
Australia
Hungary
Puerto Rico
United States
France
Israel
Mauritius
Germany
Bulgaria

location_facility:
CSG Investigational Site (#652)
CSG Investigational Site (#606)
CSG Investigational Site (#757)
CSG Investigational Site (#158)
CSG Investigational Site (#154)
CSG Investigational Site (#144)
CSG Investigational Site (#148)
CSG Investigational Site (#501)
CSG Investigational Site (#751)
CSG Investigational Site (#155)
CSG Investigational Site (#708)
CSG Investigational Site (#146)
CSG Investigational Site (# 850)
CSG Investigational Site (#135)
CSG Investigational Site (#801)
CSG Investigational Site (#514)
CSG Investigational Site (#653)
CSG Investigational Site (#656)
CSG Investigational Site (#707)
CSG Investigational Site (#311)
CSG Investigational Site (#503)
CSG Investigational Site (#116)
CSG Investigational Site (#128)
CSG Investigational Site (#603)
CSG Investigational Site (#602)
CSG Investigational Site (#804)
CSG Investigational Site (#105)
CSG Investigational Site (#655)
CSG Investigational Site (#402)
CSG Investigational Site (#160)
CSG Investigational Site (#115)
CSG Investigational Site (#130)
CSG Investigational Site (#150)
CSG Investigational Site (#502)
CSG Investigational Site (#114)
CSG Investigational Site (#709)
CSG Investigative Site (#702)
CSG Investigational Site (#800)
CSG Investigational Site (#304)
CSG Investigational Site (#505)
CSG Investigational Site (#142)
CSG Investigational Site (#200)
CSG Investigational Site (#102)
CSG Investigational Site (#314)
CSG Investigational Site (# 750)
CSG Investigational Site (#162)
CSG Investigational Site (#313)
CSG Investigational Site (#302)
CSG Investigational Site (#131)
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status_simplified: Unknown


title: An Open-label Trial, Enrolling Subjects Aged 6 Years to Less Than 18 Years Suffering From Pain Requiring Prolonged Release Opioid Treatment, to Evaluate the Safety and Efficacy of Tapentadol PR Versus Morphine PR, Followed by an Open-label Extension

lead_sponsor: Grünenthal GmbH

ipd_sharing_description: Information available on the Grünenthal Web Site (see URL below for details)

location_country:
Portugal
Spain
Italy
United Kingdom
Hungary
France
Chile
Belgium
Germany
Bulgaria

summary: Tapentadol has already been studied in adults. This study is needed to find out if tapentadol works and is safe to use in children and adolescents with long-term pain.


title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia

summary: The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.

ReferenceCitation: Arnold LM, Whitaker S, Hsu C, Jacobs D, Merante D. Efficacy and safety of mirogabalin for the treatment of fibromyalgia: results from three 13-week randomized, double-blind, placebo- and active-controlled, parallel-group studies and a 52-week open-label extension study. Curr Med Res Opin. 2019 Oct;35(10):1825-1835. doi: 10.1080/03007995.2019.1629757. Epub 2019 Jul 9.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Denmark
Serbia
Netherlands
Finland
Canada
Sweden
United States
France
Norway
Germany
Czechia


intervention_type: Dietary Supplement

title: A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis

ReferenceCitation: Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.

ReferenceCitation: Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4. Review.

location_country:
Poland
Portugal
Spain
Greece
Italy
New Zealand
Russian Federation
Lithuania
Ukraine
Hungary
France
United States
Belgium
Germany
Slovakia
Czechia

summary: The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.


title: Study MEA117106: Mepolizumab vs. Placebo as add-on Treatment for Frequently Exacerbating COPD Patients

summary:
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection.

In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD patients would translate into a reduction of COPD exacerbations. The study will determine the reduction in exacerbations in subjects who are above and below the baseline blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations, despite the use of optimized standard of care background therapy.

Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

ReferenceCitation: Pavord ID, Chapman KR, Bafadhel M, Sciurba FC, Bradford ES, Schweiker Harris S, Mayer B, Rubin DB, Yancey SW, Paggiaro P. Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO. Int J Chron Obstruct Pulmon Dis. 2021 Jun 16;16:1755-1770. doi: 10.2147/COPD.S294333. eCollection 2021.

ReferenceCitation: Condreay LD, Gao C, Bradford E, Yancey SW, Ghosh S. No genetic associations with mepolizumab efficacy in COPD with peripheral blood eosinophilia. Respir Med. 2019 Aug;155:26-28. doi: 10.1016/j.rmed.2019.07.004. Epub 2019 Jul 5.

ReferenceCitation: Pavord ID, Chanez P, Criner GJ, Kerstjens HAM, Korn S, Lugogo N, Martinot JB, Sagara H, Albers FC, Bradford ES, Harris SS, Mayer B, Rubin DB, Yancey SW, Sciurba FC. Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J Med. 2017 Oct 26;377(17):1613-1629. doi: 10.1056/NEJMoa1708208. Epub 2017 Sep 11.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Poland
Spain
Greece
Italy
Australia
Estonia
Canada
Mexico
Russian Federation
United States
France
Peru
Belgium
Norway
Sweden
Czechia


acronym: Simplify 2

title: A Phase 3, Randomized Study To Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis Who Were Treated With Ruxolitinib

lead_sponsor: Sierra Oncology, Inc.

ReferenceCitation: Harrison CN, Vannucchi AM, Platzbecker U, Cervantes F, Gupta V, Lavie D, Passamonti F, Winton EF, Dong H, Kawashima J, Maltzman JD, Kiladjian JJ, Verstovsek S. Momelotinib versus best available therapy in patients with myelofibrosis previously treated with ruxolitinib (SIMPLIFY 2): a randomised, open-label, phase 3 trial. Lancet Haematol. 2018 Feb;5(2):e73-e81. doi: 10.1016/S2352-3026(17)30237-5. Epub 2017 Dec 20.

location_country:
Spain
Italy
United Kingdom
Canada
United States
Israel
France
Germany

summary:
This study is to determine the efficacy of momelotinib (MMB) versus best available therapy (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) who were treated with ruxolitinib as measured by splenic response rate at Week 24 (SRR24).

Participants will be randomized to receive either MMB or BAT for 24 weeks during the randomized treatment phase, after which they will be eligible to receive MMB in an extended treatment phase for up to an additional 204 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those subjects planning to continue treatment with MMB following the end of the study, the End of Treatment, 30-day, 12-Week, and survival follow-up visits are not required.


title: PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246

summary: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients.

ReferenceCitation: Lehmann S, Bykov VJ, Ali D, Andrén O, Cherif H, Tidefelt U, Uggla B, Yachnin J, Juliusson G, Moshfegh A, Paul C, Wiman KG, Andersson PO. Targeting p53 in vivo: a first-in-human study with p53-targeting compound APR-246 in refractory hematologic malignancies and prostate cancer. J Clin Oncol. 2012 Oct 10;30(29):3633-9. doi: 10.1200/JCO.2011.40.7783. Epub 2012 Sep 10.

ReferenceCitation: Deneberg S, Cherif H, Lazarevic V, Andersson PO, von Euler M, Juliusson G, Lehmann S. An open-label phase I dose-finding study of APR-246 in hematological malignancies. Blood Cancer J. 2016 Jul 15;6(7):e447. doi: 10.1038/bcj.2016.60.

lead_sponsor: Aprea Therapeutics

location_country:
Spain
United Kingdom
Netherlands
Sweden
United States
France
Belgium
Germany

location_facility: Institut Català d'Oncologia, Hospital Germans Trias i Pujol

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Imperial College London, Hammersmith Hospital Campus

location_facility: Edinburgh Cancer Research Centre, The University of Edinburgh

location_facility: The Clatterbridge Cancer Center NHS Foundation Trust

location_facility: UPMC Hillman Cancer Center, Magee-Womens Hospital

location_facility: Medische oncologie, Universitair Ziekenhuis Gent

location_facility: Parkland, UT Southwestern Medical Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Bristol Haematology & Oncology Centre, University Hospitals Bristol

location_facility: University of Texas Southwestern Medical Center

location_facility: Massey Cancer Center, Virginia Commonwealth University

location_facility: Cambridge Cancer Trials Centre, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Universitario Virgen de la Victoria


title: A Prospective, Longitudinal, Multinational, Observational Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk for Poor Clinical Outcomes After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-Resistant Prostate Cancer and Men With Metastatic Prostate Cancer at Initial Diagnosis

acronym: ASPIRE-PCa

summary: The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and trigger(s) for treatment changes and to document healthcare resource utilization used to manage treatment-related complications.

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Peru
Philippines
Austria
Australia
Argentina
Indonesia
Israel
Mexico
Singapore
Egypt
Brazil
Lebanon
Canada
Germany
Taiwan
Oman
New Zealand
Thailand
Algeria
France
Korea, Republic of
Colombia
Netherlands


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients

ReferenceCitation: Klein G, Delmar P, Voyle N, Rehal S, Hofmann C, Abi-Saab D, Andjelkovic M, Ristic S, Wang G, Bateman R, Kerchner GA, Baudler M, Fontoura P, Doody R. Gantenerumab reduces amyloid-β plaques in patients with prodromal to moderate Alzheimer's disease: a PET substudy interim analysis. Alzheimers Res Ther. 2019 Dec 12;11(1):101. doi: 10.1186/s13195-019-0559-z.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Portugal
Russian Federation
Australia
Argentina
Turkey
Sweden
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Finland
Korea, Republic of
France
Netherlands

location_facility: Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit

location_facility: KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54

location_facility: Hospital General Universitario de Elche; Servicio de Neurología

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia

location_facility: Alzheimer's Research and Treatment Center

location_facility: Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center

location_facility: Inha University Hospital; Neurology Department

location_facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

location_facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology

location_facility: Jewish General Hospital / McGill University

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Medical Corporation Hakuyokai Kashiwado Hospital

location_facility: Hopital la Grave; Gerontopole - Centre de Recherche Clinique

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: CHU Rennes - hopital Hotel Dieu; Consultation Memoire - Gerontologie

location_facility: Hyogo Brain and Heart Center at Himeji; Department of Aging Brain and Cognitive Disorders

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky

location_facility: Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus

location_facility: Dokuz Eylul University Medicine Faculty; Noroloji Departmani

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Australian Alzheimer's Research Foundation

location_facility: Charing Cross Hospital; Dept of Neurosciences

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: California Neuroscience Research Medical Group, Inc

location_facility: Erasmus Mc - Locatie Centrum; Dept of Neurology

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

location_facility: Hopital Hautepierre; Centre dInvestigation Clinique

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

location_facility: Shonan Kamakura General Hospital; Neurology

location_facility: Semmelweis University; Department of Neurology

location_facility: Institution of RAMS (Mental Health Research Center of RAMS)

location_facility: National Hospital Organization Chiba-east Hospital; Neurology

location_facility: Shizuoka City Shimizu Hospital; Neurology

location_facility: Territory Neurology and Research Institute

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

location_facility: CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

location_facility: Seoul National University Bundang Hospital; Neurology Department

location_facility: Klinikum rechts der Isar der TU München; Klinikapotheke

location_facility: Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: Ewha Womans University Mokdong Hospital; Dept of Neurology

location_facility: MBAL St. Marina; First Neurology Department

location_facility: Neuropsychiatric Research; Center of Southwest Florida

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

location_facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: Irccs Multimedica Santa Maria; Unita' Di Neurologia

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Royal Adelaide Hospital; Memory Trials Centre

location_facility: Policlínica Guipuzkoa; Servicio de Neurología

location_facility: Juntendo University Urayasu Hospital; Neurology

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Miami Jewish Health Systems; Clinical Research

location_facility: Fukuoka University Hospital; Neurology and Health Care

location_facility: University of Calgary; Heritage Medical Research Clinic

location_facility: University of Utah, Center for Alzheimer's Care Imaging & Research

summary:
Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE).

A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.


ipd_sharing: No

acronym: ERA 223

title: A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)

lead_sponsor: Bayer

ReferenceType: result

ReferenceCitation: Smith M, Parker C, Saad F, Miller K, Tombal B, Ng QS, Boegemann M, Matveev V, Piulats JM, Zucca LE, Karyakin O, Kimura G, Matsubara N, Nahas WC, Nolè F, Rosenbaum E, Heidenreich A, Kakehi Y, Zhang A, Krissel H, Teufel M, Shen J, Wagner V, Higano C. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):408-419. doi: 10.1016/S1470-2045(18)30860-X. Epub 2019 Feb 6. Erratum in: Lancet Oncol. 2019 Oct;20(10):e559.

ReferenceCitation: Shore N, Higano CS, George DJ, Sternberg CN, Saad F, Tombal B, Miller K, Kalinovsky J, Jiao X, Tangirala K, Sartor O. Concurrent or layered treatment with radium-223 and enzalutamide or abiraterone/prednisone: real-world clinical outcomes in patients with metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):680-688. doi: 10.1038/s41391-020-0236-0. Epub 2020 May 13.

ReferenceCitation: Matsubara N, Kimura G, Uemura H, Uemura H, Nakamura M, Nagamori S, Mizokami A, Kikukawa H, Hosono M, Kinuya S, Krissel H, Siegel J, Kakehi Y. A randomized, double-blind, comparison of radium-223 and placebo, in combination with abiraterone acetate and prednisolone, in castration-resistant metastatic prostate cancer: subgroup analysis of Japanese patients in the ERA 223 study. Int J Clin Oncol. 2020 Apr;25(4):720-731. doi: 10.1007/s10147-019-01589-6. Epub 2019 Dec 10.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
Finland
United Kingdom
Sweden
United States
France
Israel
Norway
Belgium
Japan
Germany
Singapore

summary: To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.


title: A PHASE 2, 2-STAGE, 2-COHORT STUDY OF TALAZOPARIB (BMN 673) ADMINISTERED TO GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER

acronym: ABRAZO

summary:
The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or
Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease

ReferenceCitation: Turner NC, Telli ML, Rugo HS, Mailliez A, Ettl J, Grischke EM, Mina LA, Balmaña J, Fasching PA, Hurvitz SA, Wardley AM, Chappey C, Hannah AL, Robson ME; ABRAZO Study Group. A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO). Clin Cancer Res. 2019 May 1;25(9):2717-2724. doi: 10.1158/1078-0432.CCR-18-1891. Epub 2018 Dec 18.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
United Kingdom
Spain
United States
France
Germany

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station

location_facility: Klinikum Mutterhaus Der Borromaeerinnen Ggmbh

location_facility: Memorial Breast Cancer Center at Memorial Hospital West

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: Memorial Cancer Institute at Memorial Hospital West

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: IOZ Muenchen - lnerdisziplinaeres Onkologisches Zentrum

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Kliniken Essen Mitte Klinik fuer Gynaekologie und Gynaekologische Onkologie

location_facility: Anne Arundel Medical Center (AAMC), Annapolis Oncology and Hematology

location_facility: University of Munich (LMU) Grosshadern Hospital

location_facility: Anne Arundel Medical Center (AAMC), Research Pharmacy

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: MD Anderson Cancer Center International Espana

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Civil

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.

location_facility: Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: g.SUND Gynaekologie Kompetenzzentrum Stralsund

location_facility: Memorial Sloan Kettering Rockville Centre

location_facility: Memorial Sloan Kettering Evelyn H. Lauder Breast Center

location_facility: University of California, San Francisco: Helen Diller Comprehensive Cancer Center

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: UCLA West Medical Pharmacy Attn: Steven L. Wong, PharmD

location_facility: Hospital Universitario San Juan de Alicante

location_facility: Cambridge University Hospital NHS Foundation Trust


title: A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy

summary: The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

ReferenceCitation: Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Australia
Canada
United States
France
Germany


acronym: TOWER Study

title: A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)

ReferenceCitation: Delea TE, Amdahl J, Boyko D, Hagiwara M, Zimmerman ZF, Franklin JL, Cong Z, Hechmati G, Stein A. Cost-effectiveness of blinatumomab versus salvage chemotherapy in relapsed or refractory Philadelphia-chromosome-negative B-precursor acute lymphoblastic leukemia from a US payer perspective. J Med Econ. 2017 Sep;20(9):911-922. doi: 10.1080/13696998.2017.1344127. Epub 2017 Jul 11.

ReferenceCitation: Kantarjian H, Stein A, Gökbuget N, Fielding AK, Schuh AC, Ribera JM, Wei A, Dombret H, Foà R, Bassan R, Arslan Ö, Sanz MA, Bergeron J, Demirkan F, Lech-Maranda E, Rambaldi A, Thomas X, Horst HA, Brüggemann M, Klapper W, Wood BL, Fleishman A, Nagorsen D, Holland C, Zimmerman Z, Topp MS. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Engl J Med. 2017 Mar 2;376(9):836-847. doi: 10.1056/NEJMoa1609783.

ReferenceCitation: Dombret H, Topp MS, Schuh AC, Wei AH, Durrant S, Bacon CL, Tran Q, Zimmerman Z, Kantarjian H. Blinatumomab versus chemotherapy in first salvage or in later salvage for B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2019 Sep;60(9):2214-2222. doi: 10.1080/10428194.2019.1576872. Epub 2019 Apr 5.

ReferenceCitation: Kuchimanchi M, Zhu M, Clements JD, Doshi S. Exposure-response analysis of blinatumomab in patients with relapsed/refractory acute lymphoblastic leukaemia and comparison with standard of care chemotherapy. Br J Clin Pharmacol. 2019 Apr;85(4):807-817. doi: 10.1111/bcp.13864. Epub 2019 Feb 18.

ReferenceCitation: Stein AS, Larson RA, Schuh AC, Stevenson W, Lech-Maranda E, Tran Q, Zimmerman Z, Kormany W, Topp MS. Exposure-adjusted adverse events comparing blinatumomab with chemotherapy in advanced acute lymphoblastic leukemia. Blood Adv. 2018 Jul 10;2(13):1522-1531. doi: 10.1182/bloodadvances.2018019034.

ReferenceCitation: Topp MS, Zimmerman Z, Cannell P, Dombret H, Maertens J, Stein A, Franklin J, Tran Q, Cong Z, Schuh AC. Health-related quality of life in adults with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab. Blood. 2018 Jun 28;131(26):2906-2914. doi: 10.1182/blood-2017-09-804658. Epub 2018 May 8.

ReferenceCitation: Kantarjian HM, Zugmaier G, Brüggemann M, Wood BL, Horst HA, Zeng Y, Martinelli G. Impact of Blinatumomab Treatment on Bone Marrow Function in Patients with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia. Cancers (Basel). 2021 Nov 9;13(22). pii: 5607. doi: 10.3390/cancers13225607.

ReferenceCitation: Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704. Review.

ReferenceCitation: Jabbour E, Patel K, Jain N, Duose D, Luthra R, Short NJ, Zugmaier G, San Lucas A, Velasco K, Tran Q, Zaman F, Konopleva M, Kantarjian H. Impact of Philadelphia chromosome-like alterations on efficacy and safety of blinatumomab in adults with relapsed/refractory acute lymphoblastic leukemia: A post hoc analysis from the phase 3 TOWER study. Am J Hematol. 2021 Oct 1;96(10):E379-E383. doi: 10.1002/ajh.26281. Epub 2021 Jul 7.

ReferenceCitation: Wei AH, Ribera JM, Larson RA, Ritchie D, Ghobadi A, Chen Y, Anderson A, Dos Santos CE, Franklin J, Kantarjian H. Biomarkers associated with blinatumomab outcomes in acute lymphoblastic leukemia. Leukemia. 2021 Aug;35(8):2220-2231. doi: 10.1038/s41375-020-01089-x. Epub 2021 Feb 4.

ReferenceCitation: Rambaldi A, Huguet F, Zak P, Cannell P, Tran Q, Franklin J, Topp MS. Blinatumomab consolidation and maintenance therapy in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia. Blood Adv. 2020 Apr 14;4(7):1518-1525. doi: 10.1182/bloodadvances.2019000874.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Turkey
Mexico
Canada
Germany
Bulgaria
Taiwan
Greece
Ireland
Korea, Republic of
France

summary: The primary objective was to evaluate the effect of blinatumomab on overall survival when compared to standard of care (SOC) chemotherapy.


title: A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.

summary: This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.

lead_sponsor: Affiris AG

location_country:
Croatia
Austria
Czech Republic
France
Germany
Slovakia

location_facility: Centre Mémoire de Ressources et de Recherche, Service de Neurologie

location_facility: MUW Klin. Pharmakologie und Klinik für Neurologie

location_facility: "BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju

location_facility: Opća bolnica Varaždin, Klinika za Neurologiju

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie

location_facility: Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie

location_facility: Arzneimittelforschung Leipzig GmbH, Studienzentrum

location_facility: Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München

location_facility: CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard

location_facility: Centre Hospitalier Universitaire (CHU) de Dijon

location_facility: Christian Doppler Klinik, Univ. Klinik f. Neurologie

location_facility: Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju

location_facility: Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie

location_facility: University Hospital Motol, Clinic of Neurology


title: A 24-week, Phase IIB, Randomized, Controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Efficacy of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Diseases Who Are Not on Dialysis.

summary: This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8:CD013751. doi: 10.1002/14651858.CD013751.pub2. Review.

location_country:
Denmark
Poland
Spain
United Kingdom
Russian Federation
Australia
Canada
Sweden
Hungary
Korea, Republic of
United States
France
Japan
Germany
Czechia


type: U.S. NIH Grant/Contract

type: Other Grant/Funding Number

title: Age of Blood in Children in Pediatric Intensive Care Units

acronym: ABC-PICU

summary: ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC storage duration in 1538 critically ill children. Laboratory and observational evidence points to serious concerns about the lack of safety and effectiveness of older RBCs, especially in more vulnerable populations. Physicians and institutions have been systematically transfusing fresh RBCs to some pediatric patients primarily because of beliefs that the use of fresh RBCs improve outcomes. Conversely, the standard practice of blood banks is to deliver the oldest RBC unit in order to decrease blood wastage. To provide much needed high quality evidence to answer the question "do RBCs of reduced storage duration improve outcomes?" The ABC PICU Trial will conduct a RCT comparing development of New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) in critically ill children transfused with either RBCs stored ≤ 7 days or standard issue RBCs (expected mean RBC storage duration of 17-21 days).

ReferenceCitation: Spinella PC, Tucci M, Fergusson DA, Lacroix J, Hébert PC, Leteurtre S, Schechtman KB, Doctor A, Berg RA, Bockelmann T, Caro JJ, Chiusolo F, Clayton L, Cholette JM, Guerra GG, Josephson CD, Menon K, Muszynski JA, Nellis ME, Sarpal A, Schafer S, Steiner ME, Turgeon AF; ABC-PICU Investigators, the Canadian Critical Care Trials Group, the Pediatric Acute Lung Injury and Sepsis Investigators Network, the BloodNet Pediatric Critical Care Blood Research Network, and the Groupe Francophone de Réanimation et Urgences P. Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial. JAMA. 2019 Dec 10;322(22):2179-2190. doi: 10.1001/jama.2019.17478.

ReferenceCitation: Tucci M, Lacroix J, Fergusson D, Doctor A, Hébert P, Berg RA, Caro J, Josephson CD, Leteurtre S, Menon K, Schechtman K, Steiner ME, Turgeon AF, Clayton L, Bockelmann T, Spinella PC; Canadian Critical Care Trials Group; Pediatric Critical Care Blood Research Network (BloodNet); Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial. Trials. 2018 Jul 28;19(1):404. doi: 10.1186/s13063-018-2809-y.

lead_sponsor: Washington University School of Medicine

location_country:
Italy
Canada
United States
Israel
France

location_facility: Centre Hospitalier de I'Universite Laval

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: The Children's Hospital and University of Colorado Denver School of Medicine

location_facility: Hôpital Universitaire Necker - Enfants Malades

location_facility: James Whitcomb Riley Hospital for Children

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

lead_sponsor_type: academique


acronym: LIRA-LIXI™

title: Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes

lead_sponsor: Novo Nordisk A/S

ReferenceCitation: Nauck M, Rizzo M, Johnson A, Bosch-Traberg H, Madsen J, Cariou B. Once-Daily Liraglutide Versus Lixisenatide as Add-on to Metformin in Type 2 Diabetes: A 26-Week Randomized Controlled Clinical Trial. Diabetes Care. 2016 Sep;39(9):1501-9. doi: 10.2337/dc15-2479. Epub 2016 Jun 16.

ReferenceCitation: Hunt B, Vega-Hernandez G, Valentine WJ, Kragh N. Evaluation of the long-term cost-effectiveness of liraglutide vs lixisenatide for treatment of type 2 diabetes mellitus in the UK setting. Diabetes Obes Metab. 2017 Jun;19(6):842-849. doi: 10.1111/dom.12890. Epub 2017 Feb 23.

location_country:
United Kingdom
Italy
Latvia
Finland
Czech Republic
Lithuania
Hungary
France
Germany

summary: This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM).


title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

acronym: STARSHINE

summary: To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

ReferenceCitation: Ballard C, Atri A, Boneva N, Cummings JL, Frölich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019.

ReferenceCitation: Cummings JL, Atri A, Ballard C, Boneva N, Frölich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2.

ReferenceCitation: Atri A, Frölich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.

lead_sponsor: H. Lundbeck A/S

location_country:
Denmark
Poland
Romania
Spain
Italy
Argentina
Canada
Ukraine
United States
Chile
France
South Africa
Belgium
Germany
Bulgaria
Czechia


title: Efficacy, Safety and Tolerability of Multiple Doses of Oral Cebranopadol in Subjects With Moderate to Severe Chronic Pain Due to Diabetic Peripheral Neuropathy.

summary:
The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will be undertaken to find out if the patient's general health and well-being improves under trial treatment.

The concentrations of cebranopadol in the blood will be investigated to get a better understanding of how it is absorbed from the gut, distributed and broken down in the body, and eliminated from the body.

lead_sponsor: Tris Pharma, Inc.

location_country:
Denmark
Spain
Italy
Austria
Netherlands
United States
France
Germany


title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma

acronym: AUGMENT

summary: This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.

ReferenceCitation: Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, López-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, André M, Zachée P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.

ReferenceCitation: Leonard JP, Trneny M, Izutsu K, Fowler NH, Hong X, Zhu J, Zhang H, Offner F, Scheliga A, Nowakowski GS, Pinto A, Re F, Fogliatto LM, Scheinberg P, Flinn IW, Moreira C, Cabeçadas J, Liu D, Kalambakas S, Fustier P, Wu C, Gribben JG; AUGMENT Trial Investigators. AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2019 May 10;37(14):1188-1199. doi: 10.1200/JCO.19.00010. Epub 2019 Mar 21.

lead_sponsor: Celgene

location_country:
Poland
Brazil
Portugal
Spain
Italy
Russian Federation
United Kingdom
Puerto Rico
United States
France
China
Israel
Belgium
Japan
Germany
Turkey
Czechia

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: The Cancer Center at Hackensack University Medical Center

location_facility: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

location_facility: Coborn Cancer Center at the St. Cloud Hospital

location_facility: Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento

location_facility: Hematology-Oncology Associates of Northern NJ

location_facility: St. Petersburg Pavlov State Medical University

location_facility: Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum

location_facility: Oncology Hematology Care Sarah Cannon Research

location_facility: Chinese Academy of Medical Sciences & Peking Union Medical College

location_facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Centro di Riferimento Oncologico - IRCCS

location_facility: Fakultni Nemocnice Ostrava, Klinika hematoonkologie,

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: Kobe City Medical Center General Hospital

location_facility: Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

location_facility: IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale"

location_facility: Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: The Third Xiangya hospital of central south university

location_facility: Onkologische Schwerpunktpraxis Leer - Emden

location_facility: Fujian Medical University Union Hospital

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: National University Corporation Tohoku University, Tohoku University Hospital

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Associacao Educudora Sao Carlos AESC Hospital Giovanni Battista HGB Hospital Mae de Deus Center

location_facility: Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika

location_facility: Southend University Hospital NHS Foundation Trust, Prittlewell Chase

location_facility: Royal Liverpool University Hospital, Prescot Street

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú

location_facility: Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Centre Hospitalier Universitaire d'Avicennes

location_facility: Central Coast Medical Oncology Corporation

location_facility: North County Hematology Oncology (NCHO) - TRM, LLC.

location_facility: Nagoya Medical Center,Division of Hematology/Oncology

location_facility: Hematology-Oncology Medical Group of Orange County, Inc.

location_facility: Russian Academy of Medical Sciences Institution

location_facility: Klinkum der Stadt Villingen-Schwenningen GmbH

location_facility: West China Hospital of Sichuan University

location_facility: Florida Cancer Specialists North Region Sarah Cannon Research

location_facility: University of Louisville, J.G. Brown Cancer Center

location_facility: Mitchell Cancer Center, University of South Alabama

location_facility: Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

location_facility: Fundação Antonio Prudente - AC Camargo Câncer center

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Nesima

location_facility: Azienda Ospedaliera S. Andrea - Università La Sapienza

location_facility: The Ministry of Health and Social Development of the Tula region state institution Health Tula regio

location_facility: Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

location_facility: Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University

location_facility: The First Affiliated Hospital of Medical School of Zhejiang University

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility

summary: The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

ReferenceCitation: Globe G, Wiklund I, Mattera M, Zhang H, Revicki DA. Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma. J Patient Rep Outcomes. 2019 Apr 3;3(1):22. doi: 10.1186/s41687-019-0109-2.

lead_sponsor: Amgen

location_country:
Poland
Taiwan
Hong Kong
Greece
Ireland
Australia
Italy
Canada
New Zealand
Russian Federation
Korea, Republic of
United States
France
Puerto Rico
Germany


title: A Randomized, Double-blind Study To Evaluate the Efficacy and Safety of Cabozantinib (XL184) at 60 mg/Day Compared to a 140 mg/Day in Progressive, Metastatic Medullary Thyroid Cancer Patients

acronym: EXAMINER

summary: The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events found in previous clinical trials of 140 mg.

enrollment_type: Anticipated

ReferenceCitation: Capdevila J, Klochikhin A, Leboulleux S, Isaev P, Badiu C, Robinson B, Hughes BGM, Keam B, Parnis F, Elisei R, Gajate P, Gan HK, Kapiteijn E, Locati L, Mangeshkar M, Faoro L, Krajewska J, Jarzab B. A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer. Thyroid. 2022 May;32(5):515-524. doi: 10.1089/thy.2022.0027.

lead_sponsor: Exelixis

location_country:
Croatia
Poland
Spain
Italy
Russian Federation
Australia
Canada
Sweden
Hungary
Korea, Republic of
France
Israel
Romania
Netherlands


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

acronym: SYNERGY

summary:
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.

Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.

ReferenceCitation: Cadavid D, Mellion M, Hupperts R, Edwards KR, Calabresi PA, Drulović J, Giovannoni G, Hartung HP, Arnold DL, Fisher E, Rudick R, Mi S, Chai Y, Li J, Zhang Y, Cheng W, Xu L, Zhu B, Green SM, Chang I, Deykin A, Sheikh SI; SYNERGY study investigators. Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2019 Sep;18(9):845-856. doi: 10.1016/S1474-4422(19)30137-1. Epub 2019 Jul 5.

ReferenceCitation: Wilhelm H, Schabet M. The Diagnosis and Treatment of Optic Neuritis. Dtsch Arztebl Int. 2015 Sep 11;112(37):616-25; quiz 626. doi: 10.3238/arztebl.2015.0616. Review.

lead_sponsor: Biogen

location_country:
Poland
Serbia
Spain
Italy
Russian Federation
United Kingdom
Canada
Czech Republic
Hungary
United States
France
Netherlands

location_facility: Multiple Sclerosis Center of North Eastern New York

location_facility: Nemocnice Jihlava Prispevkova Organizace

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku

location_facility: Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy

location_facility: Republican Clinical Hospital For Rehabilitation Treatment

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet

location_facility: Fondazione Istituto San Raffaele G. Giglio di Cefalù

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: M.A.- Lek A.M.Maciejowscy Spolka Cywilna

location_facility: Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego

location_facility: Krajska Zdravotni a.s. Nemocnice Teplice Oz

location_facility: Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele

location_facility: Azienda Ospedaliera S. Antonio Abate di Gallarate

location_facility: Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku

location_facility: City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31

location_facility: OMRF Multiple Sclerosis Center of Excellence

location_facility: Michigan Institute For Neurological Disorders

location_facility: Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska


title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.

summary: Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

ReferenceCitation: DiSilvestro P, Banerjee S, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, González-Martín A, Aghajanian C, Bradley W, Mathews C, Liu J, McNamara J, Lowe ES, Ah-See ML, Moore KN; SOLO1 Investigators. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. J Clin Oncol. 2022 Sep 9:JCO2201549. doi: 10.1200/JCO.22.01549. [Epub ahead of print]

ReferenceCitation: Tattersall A, Ryan N, Wiggans AJ, Rogozińska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2:CD007929. doi: 10.1002/14651858.CD007929.pub4. Review.

ReferenceCitation: Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, González-Martín A, Aghajanian C, Bradley WH, Holmes E, Lowe ES, DiSilvestro P. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1721-1731. doi: 10.1016/S1470-2045(21)00531-3. Epub 2021 Oct 26. Erratum in: Lancet Oncol. 2021 Dec;22(12):e539.

ReferenceCitation: Friedlander M, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Lisyanskaya A, Sonke GS, Gourley C, Banerjee S, Oza A, González-Martín A, Aghajanian C, Bradley WH, Liu J, Mathews C, Selle F, Lortholary A, Lowe ES, Hettle R, Flood E, Parkhomenko E, DiSilvestro P. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):632-642. doi: 10.1016/S1470-2045(21)00098-X. Epub 2021 Apr 13.

ReferenceCitation: Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, González-Martín A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. doi: 10.1056/NEJMoa1810858. Epub 2018 Oct 21.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Korea, Republic of
United States
France
China
Israel
Japan
Netherlands

location_facility: Washington University School of Medicine

location_facility: The Tumor Hospital affiliated to China Medical Science Insti

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: Walter Reed National Military Medical Center

location_facility: Istituto Nazionale Per Cura Tumori - Milano

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: First affiliated hospital college of XianJiaotong University

location_facility: University of Texas Health Science Center of Houston

location_facility: Northern Indiana Cancer Research Consortium

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Nancy N. & J.C. Lewis Cancer and Research Pavillion

location_facility: The First Affiliated Hospital of Soochow Universit

location_facility: Obstetris and Gynecology Hospital of Fudan University

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

location_facility: West China Hospital Affiliated to Sichuan University

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie

location_facility: Chemotherapy Department, Russian Cancer Research Centre

location_facility: St.Petersburg City Oncology Dispensary, Dept. Gynecology

location_facility: Cancer Research UK and UCL Cancer Trials Centre

location_facility: Udmurtia Republic Clinical Oncology Center

location_facility: State Institution of Heath Omsk Regional Oncology Dispensary

location_facility: University of Mississippi Medical Center

location_facility: The Tumour Hospital of Harbin Medical University

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alagre

location_facility: City Hospital, Birmingham, Cancer Trials Team

location_facility: Royal Marsden Hospital and Institute of Cancer Research

location_facility: Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

location_facility: Shanghai Cancer Hospital of Fudan University

location_facility: Cleveland Clinic Cancer Center at Fairview Hospital

location_facility: St. Vincent Hospital & Health Care Center

location_facility: Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

location_facility: University of Texas Southwestern Medical Center

location_facility: Women's Hospital, Zhejaing University School of Medicine

location_facility: Istituto Regina Elena-Polo Oncologico Ifo

location_facility: Peggy and Charles Stephenson Cancer Center


title: A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

summary: The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.

ReferenceCitation: Mantia CM, Werner L, Stwalley B, Ritchings C, Tarhini AA, Atkins MB, McDermott DF, Regan MM. Sensitivity of treatment-free survival to subgroup analyses in patients with advanced melanoma treated with immune checkpoint inhibitors. Melanoma Res. 2022 Feb 1;32(1):35-44. doi: 10.1097/CMR.0000000000000793.

ReferenceCitation: Wolchok JD, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Butler MO, Hill A, Márquez-Rodas I, Haanen JBAG, Guidoboni M, Maio M, Schöffski P, Carlino MS, Lebbé C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bas T, Ritchings C, Larkin J, Hodi FS. Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma. J Clin Oncol. 2022 Jan 10;40(2):127-137. doi: 10.1200/JCO.21.02229. Epub 2021 Nov 24.

ReferenceCitation: Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Márquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schöffski P, Carlino MS, Lebbé C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28.

ReferenceCitation: Hodi FS, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Cowey CL, Lao CD, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hill A, Hogg D, Marquez-Rodas I, Jiang J, Rizzo J, Larkin J, Wolchok JD. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1480-1492. doi: 10.1016/S1470-2045(18)30700-9. Epub 2018 Oct 22. Erratum in: Lancet Oncol. 2018 Dec;19(12):e668. Lancet Oncol. 2018 Nov;19(11):e581.

ReferenceCitation: Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao CD, Wagstaff J, Schadendorf D, Ferrucci PF, Smylie M, Dummer R, Hill A, Hogg D, Haanen J, Carlino MS, Bechter O, Maio M, Marquez-Rodas I, Guidoboni M, McArthur G, Lebbé C, Ascierto PA, Long GV, Cebon J, Sosman J, Postow MA, Callahan MK, Walker D, Rollin L, Bhore R, Hodi FS, Larkin J. Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2017 Oct 5;377(14):1345-1356. doi: 10.1056/NEJMoa1709684. Epub 2017 Sep 11. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185.

ReferenceCitation: Long GV, Weber JS, Larkin J, Atkinson V, Grob JJ, Schadendorf D, Dummer R, Robert C, Márquez-Rodas I, McNeil C, Schmidt H, Briscoe K, Baurain JF, Hodi FS, Wolchok JD. Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials. JAMA Oncol. 2017 Nov 1;3(11):1511-1519. doi: 10.1001/jamaoncol.2017.1588.

ReferenceCitation: Schadendorf D, Larkin J, Wolchok J, Hodi FS, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao C, Wagstaff J, Callahan MK, Postow MA, Smylie M, Ferrucci PF, Dummer R, Hill A, Taylor F, Sabater J, Walker D, Kotapati S, Abernethy A, Long GV. Health-related quality of life results from the phase III CheckMate 067 study. Eur J Cancer. 2017 Sep;82:80-91. doi: 10.1016/j.ejca.2017.05.031. Epub 2017 Jun 23.

ReferenceCitation: Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Austria
Australia
Israel
Norway
Sweden
Canada
Switzerland
Germany
Denmark
Ireland
New Zealand
Finland
France
Netherlands

location_facility: California Pacific Medical Center Research Institute

location_facility: Comprehensive Cancer Center At Desert Regional Medical Ctr


title: A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma

acronym: Tremelimumab

summary: This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.

ReferenceCitation: Baverel P, Roskos L, Tatipalli M, Lee N, Stockman P, Taboada M, Vicini P, Horgan K, Narwal R. Exposure-Response Analysis of Overall Survival for Tremelimumab in Unresectable Malignant Mesothelioma: The Confounding Effect of Disease Status. Clin Transl Sci. 2019 Sep;12(5):450-458. doi: 10.1111/cts.12633. Epub 2019 Apr 12.

ReferenceCitation: Maio M, Scherpereel A, Calabrò L, Aerts J, Perez SC, Bearz A, Nackaerts K, Fennell DA, Kowalski D, Tsao AS, Taylor P, Grosso F, Antonia SJ, Nowak AK, Taboada M, Puglisi M, Stockman PK, Kindler HL. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Lancet Oncol. 2017 Sep;18(9):1261-1273. doi: 10.1016/S1470-2045(17)30446-1. Epub 2017 Jul 17.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: MedImmune LLC

location_country:
Denmark
Poland
Romania
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
United Kingdom
Sweden
Hungary
Korea, Republic of
United States
France
Israel
South Africa
Belgium
Germany


summary: This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1 year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft in patients with a short infrarenal neck of <15mm or juxta-renal abdominal aortic aneurysms who, in the opinion of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated Stent Graft and for whom a customised medical device is required.

lead_sponsor: Vascutek Ltd.

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Monaco
Switzerland
Sweden
France
Belgium
Germany

location_facility: Medical Care Centre for Vascular Diseases

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel

location_facility: Imperial (St Mary's / Charing X) Hospital