title: A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

summary: The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.

ipd_sharing: Undecided

lead_sponsor: Nektar Therapeutics

location_country:
Italy
Austria
Netherlands
Spain
Germany
France
Czechia
Greece
Israel
Poland
Romania
Australia
Russian Federation
New Zealand
Portugal
United States
United Kingdom

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Providence Cancer Institute, Franz Clinic

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: California Cancer Associates for Research and Excellence

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Theageneio Anticancer Oncology Hospital of Thessaloniki

location_facility: Radboud University Nijmegen Medical Centre

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Metropolitan Hospital - First Oncology Clinic

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Rocky Mountain Cancer Centers (Littleton) - USOR

location_facility: NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska

location_facility: University of North Carolina at Chapel Hill

location_facility: Washington University School of Medicine

location_facility: Lehigh Valley Physician Group (LVPG) - Hematology Oncology

location_facility: Southern California Permanente Medical Group

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: Kaiser Foundation Hospital, Inpatient Pharmacy

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University of Colorado - Cancer Center - PPDS

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

location_facility: FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF

location_facility: Frontier Cancer Center and Blood Institute

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Columbia University Medical Center - PIN

location_facility: Metropolitan Hospital - Fourth Oncology Clinic

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: University Hospitals Cleveland Medical Center

location_facility: Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud

location_facility: Utah Cancer Specialists (Salt Lake City)

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: University of Texas Southwestern Medical Center

intervention_type: Biological


design_allocation: Non-Randomized

intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: BeiGene

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
France
Belgium
Puerto Rico
Australia
United States

acronym: TIRHOL

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Huntsman Cancer Center, University of Utah

location_facility: Institut Gustave Roussy- Cancer Campus Grand Paris

location_facility: Institut d'Hematologie de Basse-Normandie

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

summary: The primary objective of the study is to evaluate the efficacy of tislelizumab in participants with relapsed/refractory classical Hodgkin lymphoma, as measured by the overall response rate per the Lugano Classification, and as determined by the investigator.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa

summary: The purpose of this extension study is to evaluate maintenance of HiSCR response at Week 104 in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials AIN457M2301 (NCT03713619) and AIN457M2302 (NCT03713619).

design_allocation: Randomized

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Guatemala
Malaysia
Greece
Australia
Belgium
Russian Federation
Taiwan
India
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Switzerland
Netherlands
Philippines
Vietnam
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Lebanon
Mexico
Czechia
Israel
Spain
Turkey


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:
Italy
United States
Spain
Germany
France
Japan
Poland
Belgium
Australia
Russian Federation
China
Canada
United Kingdom
Korea, Republic of

acronym: CREST

location_facility: AO Azienda Ospedaliera Ordine Mauriziano Di Torino

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

location_facility: University of Minnesota Health: Clinics and Surgery Center

location_facility: IRCCS Ospedale San Raffaele, URI (Urological Research Institute)

location_facility: P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research

location_facility: University of Minnesota Medical Center, Fairview

location_facility: University Health Network - Toronto General Hospital

location_facility: Pharmacy Address: University of Minnesota Medical Center, Fairview IDS Pharmacy

location_facility: Polyclinique de Limoges Site Emailleurs-Colombier

location_facility: Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa

location_facility: BHI of Omsk region "Clinical Oncological Dispensary"

location_facility: Sulpizio Cardiovascular Center at UC San Diego Health

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval

location_facility: Regional Urology Oncology & Radiation Center

location_facility: Urological Associates of Southern Arizona P.C.

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

location_facility: State Budgetary Institution of Healthcare of the Republic of Mordovia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kingston Health Sciences Centre - Kingston General Hospital

location_facility: Vancouver Prostate Centre at the Vancouver General Hospital

location_facility: University of Missouri - Ellis Fischel Cancer Center

location_facility: IRCCS Azienda Ospedaliera Universitaria Policlinico San Martino Urologia

location_facility: Fujian Medical University Affiliated First Hospital

location_facility: Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO

location_facility: Associated Medical Professionals of New York, PLLC

location_facility: Urological Associates of Southern Arizona, P.C .

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

location_facility: Federal State Budgetary Healthcare Institution Saint - Petersburg

location_facility: Hamilton Regional Laboratory Medicine Program

location_facility: First Affiliated Hospital of Xi 'an Jiaotong University

location_facility: Barts Health NHS Trust, St Bartholomew's Hospital

location_facility: IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica

location_facility: UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona

location_facility: Kaluga Regional Clinical Oncology Center

location_facility: John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy

location_facility: Montefiore Medical Center - Montefiore Medical Park

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica

location_facility: DuPage Medical Group Ambulatory Surgery Center

location_facility: Ospedale Generale Provinciale di Macerata - UOC Oncologia

location_facility: Ospedale Area Aretina Nord - UOC Oncologia Medica

location_facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Seoul National University Bundang Hospital

location_facility: ASST Sette Laghi Ospedale di Circolo Fondazione Macchi

location_facility: Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal

location_facility: University of California Irvine Medical Center

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Niigata University Medical & Dental Hospital

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: State Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"

location_facility: Second Affiliated Hospital of Suzhou University

location_facility: Kingston Health Sciences Centre -- Hotel Dieu Hospital

location_facility: Montefiore Medical Center - Oncology Investigational Services

location_facility: Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"

location_facility: Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean

location_facility: State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Kyungpook National University Chilgok Hospital

location_facility: A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation

location_facility: SBHI YaR Regional clinical oncology hospital

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: John H. Stroger, Jr. Hospital of Cook County

location_facility: Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Cleveland Clinic Taussig Cancer Center Investigational Pharmacy

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: McMaster Institute of Urology/St Joseph's Healthcare Hamilton

location_facility: Klinikum der Goethe-Universitaet Frankfurt

location_facility: Centre de recherche clinique et evaluative en oncologie (CRCEO)

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Nr 1

location_facility: Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.

location_facility: Hospital Duran i Reynals- ICO L'Hospitalet

location_facility: West China Hospital of Sichuan University

location_facility: Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego

location_facility: Private Medical Institution "Euromedservice"

location_facility: NYU Langone Medical Center (Tisch Hospital)

title: A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer

summary:
CREST: Combination of sasanlimab and alternative BCG Regimens to Evaluate outcomes with Subcutaneous anti-PD-1 Treatment

Phase 3 Design with two Cohorts. Cohort A consists of 3 study Arms (A, B and C) of BCG naive participants. Arms A and B consist of two study drugs, PF-06801591 plus BCG. Arm C consists of one study drug, BCG. Cohort B consists of B1 and B2, which test PF-06801591 and include participants who have BCG unresponsive CIS (B1) or BCG unresponsive papillary only disease (B2).

The study is designed to demonstrate that PF-06801591 plus Bacillus Calmette Guerin (BCG) (induction and maintenance periods) is superior to BCG alone (induction and maintenance periods) in prolonging event free survival (EFS) in participants with high-risk naïve non-muscle invasive bladder cancer (NMIBC) and to demonstrate that PF-06801591 plus BCG (induction period only) is superior to BCG alone (induction and maintenance periods) in prolonging EFS in participants with high-risk NMIBC. The study is also designed to estimate the CR rate of PF-06801591 alone in participants with BCG unresponsive CIS and to evaluate the EFS of PF-06801591 alone in participants with BCG unresponsive NMIBC.


type: Other Identifier

title: A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Cisplatin-Ineligible Participants With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

summary: A global, randomized phase III study to evaluate perioperative pembrolizumab with radical cystectomy + pelvic lymph node dissection (RC+PLND) versus RC+PLND alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).

ReferenceType: derived

ReferenceCitation: Galsky MD, Hoimes CJ, Necchi A, Shore N, Witjes JA, Steinberg G, Bedke J, Nishiyama H, Fang X, Kataria R, Sbar E, Jia X, Siefker-Radtke A. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021 Aug;17(24):3137-3150. doi: 10.2217/fon-2021-0273. Epub 2021 May 19.

name: Department of Medicine, Icahn School of Medicine at Mount Sinai, NY 10029, USA

family: Galsky

full_name: Matthew D Galsky

given: Matthew D

sequence: first

name: Department of Medicine, Duke University, Durham, NC 27710, USA

family: Hoimes

full_name: Christopher J Hoimes

given: Christopher J

sequence: additional

name: Department of Medical Oncology, Vita-Salute San Raffaele University & IRCCS San Raffaele Hospital, Milan, 20132, Italy

family: Necchi

full_name: Andrea Necchi

given: Andrea

name: Department of Urology, Carolina Urologic Research Center, Myrtle Beach, SC 29577, USA

family: Shore

full_name: Neal Shore

given: Neal

name: Department of Urology, Radboud University, Nijmegen Heyendaal 6500, The Netherlands

family: Witjes

full_name: J Alfred Witjes

given: J Alfred

name: Department of Urology, NYU Langone Health, NY 10017, USA

family: Steinberg

full_name: Gary Steinberg

given: Gary

name: Department of Urology, Eberhard Karls Universität Tübingen, Tübingen, 72076, Germany

family: Bedke

full_name: Jens Bedke

given: Jens

name: Department of Urology, University of Tsukuba, Ibaraki, 305-8575, Japan

family: Nishiyama

full_name: Hiroyuki Nishiyama

given: Hiroyuki

name: Department of Clinical Research, Merck & Co., Inc., Kenilworth, NJ 07033, USA

family: Fang

full_name: Xiao Fang

given: Xiao

family: Kataria

full_name: Ritesh Kataria

given: Ritesh

family: Sbar

full_name: Eric Sbar

given: Eric

family: Jia

full_name: Xieyang Jia

given: Xieyang

name: Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

family: Siefker-Radtke

full_name: Arlene Siefker-Radtke

given: Arlene

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Malaysia
Belgium
Australia
Russian Federation
Denmark
Ukraine
France
Poland
Thailand
Canada
Korea, Republic of
Sweden
Singapore
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Mexico
Israel
Spain
Turkey

location_facility: Centre Georges Francois Leclerc ( Site 0488)

location_facility: Walsall Manor Hospital-Oncology ( Site 0743)

location_facility: Hospital San Pedro de Alcantara ( Site 0697)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 0959)

location_facility: Sunnybrook Research Institute ( Site 0110)

location_facility: Seoul National University Hospital ( Site 1352)

location_facility: UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)

location_facility: Urology Associates [Nashville, TN] ( Site 0053)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0865)

location_facility: Instituto Valenciano de Oncologia - IVO ( Site 0679)

location_facility: Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)

location_facility: Clinical Hospital Saint Luka ( Site 0867)

location_facility: Inova Schar Cancer Institute ( Site 0007)

location_facility: Tallaght University Hospital ( Site 0734)

location_facility: Bon Secours St. Francis Health System ( Site 1572)

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0841)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)

location_facility: Hospital de Nuestra Senora de Valme ( Site 0693)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0962)

location_facility: Hopital Europeen Georges Pompidou ( Site 0476)

location_facility: Regional Oncology Center of Kharkiv ( Site 0958)

location_facility: Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0973)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0486)

location_facility: Georgetown University Medical Center ( Site 0022)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0456)

location_facility: Texas Oncology-Baylor Sammons Cancer Center ( Site 1552)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)

location_facility: Western Sydney Local Health District ( Site 1259)

location_facility: MI KhRC Kherson Regional Oncology Dispensary ( Site 0976)

location_facility: Thomas Jefferson University ( Site 1579)

location_facility: The Royal Marsden Foundation Trust ( Site 0726)

location_facility: Europejskie Centrum Zdrowia Otwock ( Site 1058)

location_facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)

location_facility: University Hospital Waterford ( Site 0747)

location_facility: Sakarya Universitesi Tip Fakultesi ( Site 0933)

location_facility: Policlinico Gemelli di Roma ( Site 0558)

location_facility: New England Cancer Specialists ( Site 0070)

location_facility: Providence Portland Medical Center [Portland, OR] ( Site 0095)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 1452)

location_facility: Korea University Anam Hospital ( Site 1351)

location_facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)

location_facility: Fondazione Salvatore Maugeri IRCCS ( Site 0554)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0254)

location_facility: Central Clinical Hospital with outpatient Clinic ( Site 0856)

location_facility: Vanderbilt University Medical Center ( Site 0017)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0931)

location_facility: Greater Baltimore Medical Center ( Site 0014)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 0561)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0112)

location_facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)

location_facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0492)

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 1582)

location_facility: Princess Margaret Cancer Centre ( Site 0107)

location_facility: Clinic of Bashkortostan State Medical University ( Site 0873)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1212)

location_facility: Bayandin Murmansk Regional Clinical Hospital ( Site 0859)

location_facility: Kyiv City Clinical Oncology Center ( Site 0960)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)

location_facility: Hospital Universitario Quiron Madrid ( Site 0694)

location_facility: Seoul National University Bundang Hospital ( Site 1356)

location_facility: Clatterbridge Oncology Centre ( Site 0731)

location_facility: Zhytomyr Regional Oncology Center ( Site 0971)

location_facility: Kent and Canterbury Hospital ( Site 0733)

location_facility: Shaare Zedek Medical Center ( Site 0842)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0860)

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)

location_facility: The James Cook University Hospital ( Site 0730)

location_facility: St. Joseph Heritage Healthcare ( Site 0046)

location_facility: John Wayne Cancer Institute ( Site 0075)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)

location_facility: Rigshospitalet University Hospital ( Site 0411)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1012)

location_facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)

location_facility: Assaf Harofeh Medical Center ( Site 0848)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926)

location_facility: Charleston Area Medical Center ( Site 0023)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)

location_facility: New York University Perlmutter Cancer Center ( Site 0008)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 0874)

location_facility: Lviv Regional Clinical Hospital ( Site 0955)

location_facility: Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)

location_facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)

location_facility: Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929)

location_facility: M Health Fairview Ridges Hospital ( Site 1555)

location_facility: Imperial College Healthcare NHS Trust ( Site 0745)

location_facility: Maharaj Nakorn Chiangmai Hospital ( Site 1453)

location_facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)

location_facility: Odense Universitetshospital ( Site 0413)

location_facility: Leningrad Regional Oncology Center ( Site 0868)

location_facility: University of Colorado Hospital ( Site 0098)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)

location_facility: Kursk Regional Clinical Oncology Dispensary ( Site 0854)

location_facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)

location_facility: Northwell Health- Monter Cancer Center ( Site 0083)

location_facility: UCL Saint-Luc - Oncologie Medicale ( Site 0357)

location_facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253)

location_facility: Hospital Universitario de Girona Doctor Josep Trueta ( Site 0700)

location_facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 0878)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0884)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)

location_facility: Instituto Nacional de Cancerologia. ( Site 0256)

location_facility: University Malaya Medical Centre ( Site 1702)

location_facility: First St. Petersburg State Medical University n.a. acad. I.P. Pavlov ( Site 0872)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 0852)

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)

location_facility: Lviv State Regional Oncological Center ( Site 0967)

location_facility: Hospital Clinic i Provincial ( Site 0674)

location_facility: Abramson Cancer Center of the University of Pennsylvania ( Site 0074)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 1051)

location_facility: Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)

location_facility: Hospital Universitario la Paz ( Site 0690)

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)

location_facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0691)

location_facility: Carolina Urologic Research Center ( Site 0062)

location_facility: CHU UCL Namur Site de Godinne ( Site 0354)

location_facility: A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)

location_facility: Hospital Universitario San Carlos ( Site 0678)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0031)

location_facility: Herlev og Gentofte Hospital. ( Site 0412)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0532)

intervention_type: Procedure


ReferenceCitation: Gligorov J, Doval D, Bines J, Alba E, Cortes P, Pierga JY, Gupta V, Costa R, Srock S, de Ducla S, Freudensprung U, Mustacchi G. Maintenance capecitabine and bevacizumab versus bevacizumab alone after initial first-line bevacizumab and docetaxel for patients with HER2-negative metastatic breast cancer (IMELDA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1351-60. doi: 10.1016/S1470-2045(14)70444-9. Epub 2014 Sep 28.

family: Gligorov

full_name: Joseph Gligorov

given: Joseph

family: Doval

full_name: Dinesh Doval

given: Dinesh

family: Bines

full_name: José Bines

given: José

family: Alba

full_name: Emilio Alba

given: Emilio

family: Cortes

full_name: Paulo Cortes

given: Paulo

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

family: Gupta

full_name: Vineet Gupta

given: Vineet

family: Costa

full_name: Rômulo Costa

given: Rômulo

family: Srock

full_name: Stefanie Srock

given: Stefanie

family: de Ducla

full_name: Sabine de Ducla

given: Sabine

family: Freudensprung

full_name: Ulrich Freudensprung

given: Ulrich

family: Mustacchi

full_name: Giorgio Mustacchi

given: Giorgio

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

status: Completed

lead_sponsor: Hoffmann-La Roche

enrollment_type: Actual

location_country:
Italy
Brazil
India
Saudi Arabia
Hong Kong
Spain
France
Poland
Egypt
China
Turkey

acronym: IMELDA

study_completion_date_type: Actual

title: A Randomized Study of the Effect of Maintenance Therapy With Bevacizumab + Capecitabine Versus Bevacizumab Alone on Progression-free Survival in Patients With HER2-negative Metastatic Breast Cancer That Has Not Progressed During First-line Docetaxel Plus Bevacizumab Therapy

summary: This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.

status_simplified: Completed


lead_sponsor: Ipsen

location_country:
United Kingdom
France
Czechia
Lithuania
Poland
Hungary
Belgium
Russian Federation
Spain
Moldova, Republic of
Latvia
Ukraine

location_facility: DU "Instytut medychnoi radiologii im. S.P. Grygorieva AMN Ukrainy"

location_facility: DU "Natsionalnyi instytut raku", m. Kyiv

location_facility: University Hospitals of Leicester, Leicester Royal Infirmary

location_facility: Krajska zdravotni s.r.o. - Masarykova nemocnice Usti nad Labem

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Orvos-és Gyógyszerésztudományi Centrum

location_facility: Saint-Petersburg GUZ City Clinical Oncology Dispensary

location_facility: Medical Radiology Research Center of RAMS

location_facility: Beatson Oncology Centre, Gartnavel General Hospital

location_facility: GUZ "Orenburg Regional Clinical Oncology Dispensary"

location_facility: BAZ Megyei Kórház és Egyetemi Oktató Kórház, Sugártherápiás és Onkológiai Intézet

location_facility: Kauno universiteto medicinos kliniku onkologijos ligonine

location_facility: Oddział Ginekologii Onkologicznej Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu

location_facility: Vilniaus universiteto Onkologijos institutas

location_facility: FGU "Research Institute of Oncology named after N.N.Petrov"

location_facility: Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno-diagnostychnyi tsentr

location_facility: Riga Eastern CUH - Latvian Oncology Centre, Department No 9

location_facility: GUZ of Stavropol Territorial Clinical Oncological Dispensary, Pyatigorsk Branch

location_facility: Oblasnyi onkologichnyi klinichnyi dyspanser, misto Uzhgorod. Uzhgorods'kyi natsionalnyi universytet

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: University of Liverpool Clatterbridge Centre for Oncology

location_facility: Centrum Onkologii Instytut Marii Sklodowskiej Curie

title: A Phase II International Multicentre Randomised Open Label Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer

summary: This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA) on progression free survival (PFS) in post menopausal patients with endometrial cancer.


title: A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD

acronym: INTENSITY

summary: This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.

ReferenceCitation: Buhl R, Dunn LJ, Disdier C, Lassen C, Amos C, Henley M, Kramer B; INTENSITY study investigators. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J. 2011 Oct;38(4):797-803. doi: 10.1183/09031936.00191810. Epub 2011 May 26.

family: Buhl

full_name: R. Buhl

given: R.

family: Dunn

full_name: L. J. Dunn

given: L. J.

family: Disdier

full_name: C. Disdier

given: C.

family: Lassen

full_name: C. Lassen

family: Amos

full_name: C. Amos

family: Henley

full_name: M. Henley

given: M.

family: Kramer

full_name: B. Kramer

given: B.

name: on behalf of the INTENSITY study investigators

journal_name: European Respiratory Journal

evidence: open (via free pdf)

license_normalized: no license

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

location_country:
Finland
Greece
Belgium
Russian Federation
Denmark
France
Poland
Slovakia
Norway
Canada
Colombia
Switzerland
Hungary
United States
Germany
United Kingdom
Italy
Austria
Mexico
Israel
Spain
Turkey

location_facility:
Novartis Investigative SIte
Novartis Investigator Site
Novartis Investigative Site
Novartis Investigative Center


title: A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD

acronym: INVIGORATE

summary: This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

ReferenceCitation: Decramer ML, Chapman KR, Dahl R, Frith P, Devouassoux G, Fritscher C, Cameron R, Shoaib M, Lawrence D, Young D, McBryan D; INVIGORATE investigators. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir Med. 2013 Sep;1(7):524-33. doi: 10.1016/S2213-2600(13)70158-9. Epub 2013 Aug 21.

family: Decramer

full_name: Marc L Decramer

given: Marc L

family: Chapman

full_name: Kenneth R Chapman

given: Kenneth R

family: Dahl

full_name: Ronald Dahl

given: Ronald

family: Frith

full_name: Peter Frith

given: Peter

family: Devouassoux

full_name: Gilles Devouassoux

given: Gilles

family: Fritscher

full_name: Carlos Fritscher

given: Carlos

family: Cameron

full_name: Ray Cameron

given: Ray

family: Shoaib

full_name: Muhammad Shoaib

given: Muhammad

family: Lawrence

full_name: David Lawrence

given: David

family: Young

full_name: David Young

family: McBryan

full_name: Danny McBryan

given: Danny

journal_name: The Lancet Respiratory Medicine

location_country:
Peru
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Iceland
India
Costa Rica
France
Poland
Lithuania
Slovakia
Thailand
Argentina
Canada
Turkey
Colombia
South Africa
Sweden
Switzerland
Netherlands
Philippines
Hungary
China
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Venezuela
Israel
Spain
Estonia
Latvia


title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)

acronym: BRISK PS

summary: The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib

ReferenceCitation: Lencioni R, Montal R, Torres F, Park JW, Decaens T, Raoul JL, Kudo M, Chang C, Ríos J, Boige V, Assenat E, Kang YK, Lim HY, Walters I, Llovet JM. Objective response by mRECIST as a predictor and potential surrogate end-point of overall survival in advanced HCC. J Hepatol. 2017 Jun;66(6):1166-1172. doi: 10.1016/j.jhep.2017.01.012. Epub 2017 Jan 26.

family: Lencioni

full_name: Riccardo Lencioni

given: Riccardo

family: Montal

full_name: Robert Montal

given: Robert

family: Torres

full_name: Ferran Torres

given: Ferran

family: Park

full_name: Joong-Won Park

given: Joong-Won

family: Decaens

full_name: Thomas Decaens

given: Thomas

family: Raoul

full_name: Jean-Luc Raoul

given: Jean-Luc

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Chang

full_name: Charissa Chang

given: Charissa

family: Ríos

full_name: José Ríos

given: José

family: Boige

full_name: Valerie Boige

given: Valerie

family: Assenat

full_name: Eric Assenat

given: Eric

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

family: Lim

full_name: Ho-Yeong Lim

given: Ho-Yeong

family: Walters

full_name: Ian Walters

given: Ian

family: Llovet

full_name: Josep M. Llovet

given: Josep M.

journal_name: Journal of Hepatology

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

version: acceptedVersion

ReferenceCitation: Llovet JM, Decaens T, Raoul JL, Boucher E, Kudo M, Chang C, Kang YK, Assenat E, Lim HY, Boige V, Mathurin P, Fartoux L, Lin DY, Bruix J, Poon RT, Sherman M, Blanc JF, Finn RS, Tak WY, Chao Y, Ezzeddine R, Liu D, Walters I, Park JW. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol. 2013 Oct 1;31(28):3509-16. doi: 10.1200/JCO.2012.47.3009. Epub 2013 Aug 26.

name: Josep M. Llovet and Charissa Chang, Icahn School of Medicine at Mount Sinai, New York, NY; Josep M. Llovet and Jordi Bruix, Institut d'investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) –Hospital Clinic, University of Barcelona, Barcelona, Spain; Thomas Decaens, University of Paris-Est, and Institut National de la Santé et de la Recherche Médicale, Creteil; Jean-Luc Raoul, Institut Paoli Calmette, Marseille; Eveline Boucher, Service d'Oncologie Médicale, Central Eugene Marquis, Rennes; Eric Assenat,...

family: Boucher

full_name: Eveline Boucher

given: Eveline

publisher: American Society of Clinical Oncology (ASCO)

title: Brivanib in Patients With Advanced Hepatocellular Carcinoma Who Were Intolerant to Sorafenib or for Whom Sorafenib Failed: Results From the Randomized Phase III BRISK-PS Study

location_country:
Italy
United States
Brazil
India
Hong Kong
Mexico
Spain
Germany
France
Japan
Greece
Belgium
Argentina
Puerto Rico
China
Russian Federation
Canada
Korea, Republic of
Taiwan

location_facility: The University Of Texas Health Science Center


title: Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses

summary:
The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse.

The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Freedman

full_name: Mark S. Freedman

given: Mark S.

family: Meca-Lallana

full_name: José E. Meca-Lallana

given: José E.

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

family: Kim

full_name: Byoung Joon Kim

given: Byoung Joon

family: Parajeles

full_name: Alexander Parajeles

given: Alexander

family: Edwards

full_name: Keith R. Edwards

given: Keith R.

family: Gold

full_name: Ralf Gold

given: Ralf

family: Korideck

full_name: Houari Korideck

given: Houari

family: Chavin

full_name: Jeffrey Chavin

given: Jeffrey

family: Poole

full_name: Elizabeth M. Poole

given: Elizabeth M.

family: Coyle

full_name: Patricia K. Coyle

given: Patricia K.

currency_apc_doaj: GBP

journal_name: BMC Neurology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University of Ottawa - uO Research

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Sprenger T, Kappos L, Radue EW, Gaetano L, Mueller-Lenke N, Wuerfel J, Poole EM, Cavalier S. Association of brain volume loss and long-term disability outcomes in patients with multiple sclerosis treated with teriflunomide. Mult Scler. 2020 Sep;26(10):1207-1216. doi: 10.1177/1352458519855722. Epub 2019 Jun 14.

name: University Hospital Basel, Basel, Switzerland/ Department of Neurology, DKD Helios Klinik Wiesbaden, Wiesbaden, Germany

family: Sprenger

full_name: Till Sprenger

given: Till

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

family: Radue

full_name: Ernst-Wilhelm Radue

given: Ernst-Wilhelm

name: Medical Image Analysis Center, Basel, Switzerland/ Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital Basel and University of Basel, Basel, Switzerland

family: Gaetano

full_name: Laura Gaetano

given: Laura

name: Medical Image Analysis Center, Basel, Switzerland/ Department of Biomedical Engineering, University of Basel, Basel, Switzerland

name: Global Scientific Communications, Sanofi, Cambridge, MA, USA

location_country:
Finland
Russian Federation
Denmark
Czech Republic
Ukraine
Estonia
France
Poland
Norway
Canada
Chile
Sweden
Switzerland
Netherlands
Portugal
Germany
United Kingdom
United States
Italy
Austria
Turkey

location_facility:
Investigational Site Number 2405
Investigational Site Number 1209
Investigational Site Number 1207
Investigational Site Number 4601
Investigational Site Number 2004
Investigational Site Number 1210
Investigational Site Number 3501
Investigational Site Number 2409
Investigational Site Number 2001
Investigational Site Number 1203
Investigational Site Number 2609
Investigational Site Number 3008
Investigational Site Number 2803
Investigational Site Number 5001
Investigational Site Number 3506
Investigational Site Number 3205
Investigational Site Number 3510
Investigational Site Number 2003
Investigational Site Number 2007
Investigational Site Number 2604
Investigational Site Number 3002
Investigational Site Number 3604
Investigational Site Number 2407
Investigational Site Number 1602
Investigational Site Number 3802
Investigational Site Number 2005
Investigational Site Number 1211
Investigational Site Number 1032
Investigational Site Number 4804
Investigational Site Number 2809
Investigational Site Number 2606
Investigational Site Number 2808
Investigational Site Number 3505
Investigational Site Number 2201
Investigational Site Number 1202
Investigational Site Number 3203
Investigational Site Number 1212
Investigational Site Number 2206
Investigational Site Number 2404
Investigational Site Number 3507
Investigational Site Number 2009
Investigational Site Number 2824
Investigational Site Number 3804
Investigational Site Number 4203
Investigational Site Number 4604
Investigational Site Number 1204
Investigational Site Number 1603
Investigational Site Number 5005
Investigational Site Number 4605
Investigational Site Number 2813
Investigational Site Number 2202
Investigational Site Number 2827
Investigational Site Number 2011
Investigational Site Number 3504
Investigational Site Number 2406
Investigational Site Number 1604
Investigational Site Number 3208
Investigational Site Number 2415
Investigational Site Number 2010
Investigational Site Number 3201
Investigational Site Number 2410
Investigational Site Number 2413
Investigational Site Number 3206
Investigational Site Number 3004
Investigational Site Number 1208
Investigational Site Number 2601
Investigational Site Number 3001
Investigational Site Number 3003
Investigational Site Number 2203
Investigational Site Number 2402
Investigational Site Number 3601
Investigational Site Number 2000
Investigational Site Number 3207
Investigational Site Number 3202
Investigational Site Number 1033
Investigational Site Number 1601
Investigational Site Number 4802
Investigational Site Number 3801
Investigational Site Number 2812
Investigational Site Number 1037
Investigational Site Number 1206
Investigational Site Number 5006
Investigational Site Number 2008
Investigational Site Number 2012
Investigational Site Number 3803
Investigational Site Number 2814
Investigational Site Number 3007
Investigational Site Number 2411
Investigational Site Number 3005
Investigational Site Number 3509
Investigational Site Number 1038
Investigational Site Number 3502
Investigational Site Number 1501
Investigational Site Number 2414
Investigational Site Number 3401
Investigational Site Number 2401
Investigational Site Number 2403
Investigational Site Number 1205
Investigational Site Number 3006
Investigational Site Number 2607
Investigational Site Number 3508
Investigational Site Number 1201
Investigational Site Number 1502
Investigational Site Number 1802
Investigational Site Number 3805
Investigational Site Number 4201
Investigational Site Number 2608
Investigational Site Number 4602
Investigational Site Number 4801
Investigational Site Number 5003
Investigational Site Number 2819
Investigational Site Number 2600
Investigational Site Number 2602
Investigational Site Number 4101
Investigational Site Number 3009
Investigational Site Number 2408


ReferenceType: result

ReferenceCitation: Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.

family: Bruix

full_name: Jordi Bruix

given: Jordi

family: Takayama

full_name: Tadatoshi Takayama

given: Tadatoshi

family: Mazzaferro

full_name: Vincenzo Mazzaferro

given: Vincenzo

family: Chau

full_name: Gar-Yang Chau

given: Gar-Yang

family: Yang

full_name: Jiamei Yang

given: Jiamei

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Cai

full_name: Jianqiang Cai

given: Jianqiang

family: Poon

full_name: Ronnie T Poon

given: Ronnie T

family: Han

full_name: Kwang-Hyub Han

given: Kwang-Hyub

family: Tak

full_name: Won Young Tak

given: Won Young

family: Lee

full_name: Han Chu Lee

given: Han Chu

family: Song

full_name: Tianqiang Song

given: Tianqiang

family: Roayaie

full_name: Sasan Roayaie

given: Sasan

family: Bolondi

full_name: Luigi Bolondi

given: Luigi

full_name: Kwan Sik Lee

given: Kwan Sik

family: Makuuchi

full_name: Masatoshi Makuuchi

family: Souza

full_name: Fabricio Souza

given: Fabricio

family: Berre

full_name: Marie-Aude Le Berre

given: Marie-Aude Le

family: Meinhardt

full_name: Gerold Meinhardt

given: Gerold

family: Llovet

full_name: Josep M Llovet

given: Josep M

ReferenceCitation: Pinyol R, Montal R, Bassaganyas L, Sia D, Takayama T, Chau GY, Mazzaferro V, Roayaie S, Lee HC, Kokudo N, Zhang Z, Torrecilla S, Moeini A, Rodriguez-Carunchio L, Gane E, Verslype C, Croitoru AE, Cillo U, de la Mata M, Lupo L, Strasser S, Park JW, Camps J, Solé M, Thung SN, Villanueva A, Pena C, Meinhardt G, Bruix J, Llovet JM. Molecular predictors of prevention of recurrence in HCC with sorafenib as adjuvant treatment and prognostic factors in the phase 3 STORM trial. Gut. 2019 Jun;68(6):1065-1075. doi: 10.1136/gutjnl-2018-316408. Epub 2018 Aug 14.

family: Pinyol

full_name: Roser Pinyol

given: Roser

family: Montal

full_name: Robert Montal

given: Robert

family: Bassaganyas

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Padua - Padua Research Archive

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

ReferenceCitation: Bouattour M, Soubrane O, de Gramont A, Faivre S. Adjuvant therapies in advanced hepatocellular carcinoma: moving forward from the STORM. Trials. 2016 Nov 25;17(1):563.

ReferenceCitation: Kudo M. Adjuvant therapy after curative treatment for hepatocellular carcinoma. Oncology. 2011;81 Suppl 1:50-5. doi: 10.1159/000333259. Epub 2011 Dec 22. Review.

title: Adjuvant Therapy after Curative Treatment for Hepatocellular Carcinoma

ReferenceCitation: Printz C. Clinical trials of note. Sorafenib as adjuvant treatment in the prevention of disease recurrence in patients with hepatocellular carcinoma (HCC) (STORM). Cancer. 2009 Oct 15;115(20):4646. doi: 10.1002/cncr.24673.

title: Clinical trials of note

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Argentina
Canada
Korea, Republic of
Chile
Sweden
Hong Kong
Switzerland
Bulgaria
Singapore
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
New Zealand
Spain

title: A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.

summary: To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).


ReferenceType: background

ReferenceCitation: Khullar V, Amarenco G, Angulo JC, Cambronero J, Høye K, Milsom I, Radziszewski P, Rechberger T, Boerrigter P, Drogendijk T, Wooning M, Chapple C. Efficacy and tolerability of mirabegron, a β(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013 Feb;63(2):283-95. doi: 10.1016/j.eururo.2012.10.016. Epub 2012 Nov 6.

ReferenceCitation: Desroziers K, Aballéa S, Maman K, Nazir J, Odeyemi I, Hakimi Z. Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health Qual Life Outcomes. 2013 Nov 19;11:200. doi: 10.1186/1477-7525-11-200.

family: Desroziers

full_name: Katia Desroziers

given: Katia

family: Aballéa

full_name: Samuel Aballéa

given: Samuel

family: Maman

full_name: Khaled Maman

given: Khaled

family: Nazir

full_name: Jameel Nazir

given: Jameel

family: Odeyemi

full_name: Isaac Odeyemi

given: Isaac

family: Hakimi

full_name: Zalmai Hakimi

given: Zalmai

journal_name: Health and Quality of Life Outcomes

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer

publisher_group: Springer

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Iceland
Ukraine
Spain
France
Poland
Lithuania
Slovakia
Norway
South Africa
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Czechia
Belarus
Latvia

acronym: SCORPIO

title: A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder

summary: The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.


title: A 48-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Evaluation of the Comparative Efficacy, Safety, and Tolerability of Exelon® 10 and 15 cm^2 Patch in Patients With Mild to Moderate Alzheimer's Disease (AD) Showing Functional and Cognitive Decline

summary: The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm^2.

ReferenceCitation: Molinuevo JL, Frölich L, Grossberg GT, Galvin JE, Cummings JL, Krahnke T, Strohmaier C. Responder analysis of a randomized comparison of the 13.3 mg/24 h and 9.5 mg/24 h rivastigmine patch. Alzheimers Res Ther. 2015 Mar 8;7(1):9. doi: 10.1186/s13195-014-0088-8. eCollection 2015.

family: Molinuevo

full_name: José L Molinuevo

given: José L

family: Frölich

full_name: Lutz Frölich

given: Lutz

family: Grossberg

full_name: George T Grossberg

given: George T

family: Galvin

full_name: James E Galvin

given: James E

family: Cummings

full_name: Jeffrey L Cummings

given: Jeffrey L

family: Krahnke

full_name: Tillmann Krahnke

given: Tillmann

family: Strohmaier

full_name: Christine Strohmaier

given: Christine

journal_name: Alzheimer's Research & Therapy

ReferenceCitation: Grossberg G, Cummings J, Frölich L, Bellelli G, Molinuevo JL, Krahnke T, Strohmaier C. Efficacy of higher dose 13.3 mg/24 h rivastigmine patch on instrumental activities of daily living in patients with mild-to-moderate Alzheimer's disease. Am J Alzheimers Dis Other Demen. 2013 Sep;28(6):583-91. doi: 10.1177/1533317513495104.

name: Department of Neurology and Psychiatry, St Louis University School of Medicine, St Louis, MO, USA

full_name: George Grossberg

given: George

name: Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV and Cleveland, OH, USA

full_name: Jeffrey Cummings

given: Jeffrey

name: Department of Geriatric Psychiatry, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany

name: Department of Health Sciences and Alzheimer Evaluation Unit, University Milano-Bicocca, Monza and Geriatric Research Group, Brescia, Italy

family: Bellelli

full_name: Giuseppe Bellelli

given: Giuseppe

name: Alzheimer’s Disease and Other Cognitive Disorders Unit, ICN, Hospital Clínic i Universitari, Barcelona, Spain

full_name: José L. Molinuevo

given: José L.

journal_name: American Journal of Alzheimer's Disease & Other Dementiasr

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

title: Efficacy of Higher Dose 13.3 mg/24 h Rivastigmine Patch on Instrumental Activities of Daily Living in Patients with Mild-to-Moderate Alzheimer's Disease

location_country:
Italy
United States
Switzerland
France
Spain
Germany
Canada

location_facility:
Novartis Investigative Site
Novartis investigative site


title: A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily

summary: The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.

ReferenceCitation: Nielsen R, Kankaanranta H, Bjermer L, Lange P, Arnetorp S, Hedegaard M, Stenling A, Mittmann N. Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries. Respir Med. 2013 Nov;107(11):1709-21. doi: 10.1016/j.rmed.2013.06.007. Epub 2013 Jul 13.

family: Nielsen

full_name: Rune Nielsen

given: Rune

family: Kankaanranta

full_name: Hannu Kankaanranta

given: Hannu

family: Bjermer

full_name: Leif Bjermer

given: Leif

family: Lange

full_name: Peter Lange

given: Peter

family: Arnetorp

full_name: Sofie Arnetorp

given: Sofie

family: Hedegaard

full_name: Morten Hedegaard

given: Morten

family: Stenling

full_name: Anna Stenling

given: Anna

family: Mittmann

full_name: Nicole Mittmann

given: Nicole

journal_name: Respiratory Medicine

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Mittmann N, Hernandez P, Mellström C, Brannman L, Welte T. Cost effectiveness of budesonide/formoterol added to tiotropium bromide versus placebo added to tiotropium bromide in patients with chronic obstructive pulmonary disease: Australian, Canadian and Swedish healthcare perspectives. Pharmacoeconomics. 2011 May;29(5):403-14. doi: 10.2165/11590380-000000000-00000.

family: Hernandez

full_name: Paul Hernandez

given: Paul

family: Mellström

full_name: Carl Mellström

given: Carl

family: Brannman

full_name: Lance Brannman

given: Lance

family: Welte

full_name: Tobias Welte

given: Tobias

journal_name: PharmacoEconomics

title: Cost Effectiveness of Budesonide/Formoterol Added to Tiotropium Bromide versus Placebo Added to Tiotropium Bromide in Patients with Chronic Obstructive Pulmonary Disease

ReferenceCitation: Partridge MR, Miravitlles M, Ståhl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. doi: 10.1183/09031936.00123709. Epub 2009 Nov 6.

family: Partridge

full_name: M. R. Partridge

given: M. R.

family: Miravitlles

full_name: M. Miravitlles

given: M.

family: Stahl

ReferenceCitation: Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, Kessler R. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50. doi: 10.1164/rccm.200904-0492OC. Epub 2009 Jul 30.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Efficacy and Tolerability of Budesonide/Formoterol Added to Tiotropium in Patients with Chronic Obstructive Pulmonary Disease

location_country: Sweden France Poland Slovakia Hungary Australia Spain Germany Canada


location_country:
Brazil
Hong Kong
Mexico
Philippines
Germany
France
Korea, Republic of
Singapore
Belgium
Argentina
Australia
Spain
United States
United Kingdom
Canada
Taiwan
Colombia

location_facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University/Department of Surgery

location_facility: University of Iowa Hospitals and Clinics

location_facility: The Strelitz Diabetes Institute of Eastern Virginia Medical School

location_facility: Centro de Oncologia do Instituto de Radiologia

location_facility: Chang Gung Medical Foundation, Linkou Branch

location_facility: Taichung Veterans General Hospital, Department of Surgery

location_facility: QEII Health Sciences Centre - Nova Scotia Cancer Centre

location_facility: Cardiology Department, Wythenshawe Hospital

location_facility: Management Offices, 4th Floor, Thomas Guy House

location_facility: Department of Clinical Oncology, Tuen Mun Hospital

location_facility: Royal Adelaide Hospital, Department of Medical Oncology

location_facility: National Cancer Center/Department of Medical Oncology

location_facility: Cliniques Universitaires Saint-Luc, Oncologie

location_facility: Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine

location_facility: Asan Medical Center, Division of Oncology, Department of Internal Medicine

location_facility: US Oncology Research and Clinical Pharmacy (Drug Shipment Only)

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: National Taiwan University Hospital/Department of Oncology

location_facility: National University Hospital/Department of Heamatology-Oncology

location_facility: QEII Health Sciences Centre - Halifax Infirmary Site

location_facility: Tuen Mun Hospital, Department of Clinical Oncology

location_facility: UZ Gasthuisberg, Department Internal Medicine - Gastroenterology - Gastro-intestinal Oncology

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Hospital Universitario San Vicente de Paul

location_facility: Division of Haematology/Oncology, Department of Medicine, Queen Mary Hospital,

location_facility: Seoul National University Hospital / Department of Internal Medecine

location_facility: Groupe Hospitalier Cochin, Cancer Quest AP-HP

location_facility: Centro Oncologico Md Anderson International España

location_facility: Seoul National University Bundang Hospital

location_facility: QEII Health Sciences Centre - Victoria General Site

location_facility: Rhoen Klinikum Meiningen, Gynaekologie und Geburtshilfe

location_facility: Yeungnam University Medical Center/Department of Internal medicine

location_facility: Universitaetsklinikum Charité, Campus Virchow Klinikum

location_facility: Fundacion Centro de Investigacion Clinica CIC

location_facility: Klinik fuer Innere Medizin, Gastroenterologie, Onkologie, Endokrinologie

location_facility: Klinik fuer Frauenheilkunde und Geburtshilfe, Universitaetsklinikum Schleswig-Holstein

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Universitaetsklinikum Giessen und Marburg, Standort Marburg

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Luebeck

location_facility: Koo Foundation Sun Yat-Sen Cancer Center, Div. of Hematology/Oncology

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Emory University, Winship Cancer Institute

location_facility: Cliniques Universitaires Saint Luc / Gastroentérologie

location_facility: Washington University School of Medicine, Siteman Cancer Center

location_facility: Frauenklinik und Poliklinik, Klinikum rechts der Isar, Technische Universitaet Muenchen

location_facility: Queen Elizabeth Hospital, Department of Clinical Oncology

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez Centro Universitario contra el cancer

title: An Open-label Sunitinib Malate (su011248) Continuation Protocol For Patients Who Have Completed A Prior Sunitinib Study And Are Judged By The Investigator To Have The Potential To Benefit From Sunitinib Treatment

summary: This is a study using sunitinib for patients ending treatment on a previous sunitinib malate protocol to continue to receive sunitinib. The patient must have been enrolled in one of the following studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.


ReferenceCitation: Butts C, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Ciuleanu TE, Bosquée L, Trigo JM, Spira A, Tremblay L, Nyman J, Ramlau R, Helwig C, Falk MH, Shepherd FA. START: A phase III study of L-BLP25 cancer immunotherapy for unresectable stage III non-small cell lung cancer. American Society of Clinical Oncology - 49th Annual Meeting. 2013; Abstr No. 7500.

ReferenceCitation: Shepherd FA, Socinski MA, Mitchell P, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Helwig C, Schroeder A, Butts C. Updated analysis and secondary endpoints with L-BLP25 in unresectable stage III non-small cell lung cancer in the phase III START study. European Society for Medical Oncology 38th Congress - ECCO 17, ESMO 38, ESTRO 32. 2013. Abstr No. 3419.

ReferenceCitation: Mitchell P, Butts C, Socinski M, Thatcher N, Wichardt-Johansson G, Ellis P, Gladkov O, Pereira J, Eberhardt W, Horwood K, Szczesna A, Helwig C, Schröder A, Shepherd F. Tecemotide (L-BLP25) in unresectable stage III non-small cell lung cancer in the phase III START study: Further endpoint and exploratory biomarker results. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2779.

ReferenceCitation: Thatcher N, Shepherd FA, Mitchell P, Socinski MA, Paredes A, Lambrechts M, Thomas M, Kollmeier J, Zemanová M, Sadjadian P, Peylan-Ramu N, Helwig C, Schröder A, Butts C. Geographic differences in the combined-modality treatment of stage III unresectable non-small cell lung cancer: Results from a global phase III trial of tecemotide (L-BLP25). World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2712.

ReferenceCitation: Socinski M, Butts C, Mitchell P, Thatcher N, Scagliotti G, Robinet G, Martin C, Zukin M, Ragulin Y, Bonomi P, Yang CH, Regnault A, Helwig C, de Nigris E, Shepherd F. Exploration of patient health status as measured by the generic preference-based questionnaire EQ-5D alongside the START trial of tecemotide in non-small cell lung cancer. World Conference on Lung Cancer - 15th. 2013; Abstr. No. 2744.

ReferenceCitation: Butts C, Socinski MA, Mitchell PL, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Ciuleanu TE, Bosquée L, Trigo JM, Spira A, Tremblay L, Nyman J, Ramlau R, Wickart-Johansson G, Ellis P, Gladkov O, Pereira JR, Eberhardt WE, Helwig C, Schröder A, Shepherd FA; START trial team. Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jan;15(1):59-68. doi: 10.1016/S1470-2045(13)70510-2. Epub 2013 Dec 9.

family: Butts

full_name: Charles Butts

given: Charles

family: Socinski

full_name: Mark A Socinski

given: Mark A

family: Mitchell

full_name: Paul L Mitchell

given: Paul L

family: Thatcher

full_name: Nick Thatcher

given: Nick

family: Havel

full_name: Libor Havel

given: Libor

family: Krzakowski

full_name: Maciej Krzakowski

given: Maciej

family: Nawrocki

full_name: Sergiusz Nawrocki

given: Sergiusz

family: Ciuleanu

full_name: Tudor-Eliade Ciuleanu

given: Tudor-Eliade

family: Bosquée

full_name: Lionel Bosquée

given: Lionel

family: Trigo

full_name: José Manuel Trigo

given: José Manuel

family: Spira

full_name: Alexander Spira

given: Alexander

family: Tremblay

full_name: Lise Tremblay

given: Lise

family: Nyman

full_name: Jan Nyman

given: Jan

family: Ramlau

full_name: Rodryg Ramlau

given: Rodryg

family: Wickart-Johansson

full_name: Gun Wickart-Johansson

given: Gun

family: Ellis

full_name: Peter Ellis

family: Gladkov

full_name: Oleg Gladkov

given: Oleg

family: Pereira

full_name: José Rodrigues Pereira

given: José Rodrigues

family: Eberhardt

full_name: Wilfried Ernst Erich Eberhardt

given: Wilfried Ernst Erich

family: Helwig

full_name: Christoph Helwig

given: Christoph

family: Schröder

full_name: Andreas Schröder

given: Andreas

family: Shepherd

full_name: Frances A Shepherd

given: Frances A

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of Liège - Open Repository and Bibliography

ReferenceCitation: DeGregorio M, Soe L, Wolf M. Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small cell lung cancer (START): a randomized, double-blind, phase III trial. J Thorac Dis. 2014 Jun;6(6):571-3. doi: 10.3978/j.issn.2072-1439.2014.05.15.

ReferenceCitation: Mitchell P, Thatcher N, Socinski MA, Wasilewska-Tesluk E, Horwood K, Szczesna A, Martín C, Ragulin Y, Zukin M, Helwig C, Falk M, Butts C, Shepherd FA. Tecemotide in unresectable stage III non-small-cell lung cancer in the phase III START study: updated overall survival and biomarker analyses. Ann Oncol. 2015 Jun;26(6):1134-1142. doi: 10.1093/annonc/mdv104. Epub 2015 Feb 26.

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
India
France
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility: Hematology and Oncology Specialists, LLC

location_facility: Joliet Oncology-Hematology Associates, Ltd.

location_facility: University of Minnesota Physicians, Masonic Cancer Center

location_facility: Clinical Trials and Research Associates, Inc.

location_facility: Hospital de Clinicas de Porto Alegre, Dept. de Endocrinologia

location_facility: University of Maryland, Marlene and Steward Greenbaum Cancer Center

location_facility: Instituto do Cancer Arnaldo Vieira de Caralho-Onco-pneumonia

location_facility: Hospital Nossa Senhora da Conceicao, Centro de Pesquisas Medicas e Ensaios Clinicos

location_facility: Univ. of Pennsylvania Abramson Cancer Center

location_facility: Sociedad Intaliana de Beneficencia en Buenos Aires, Hospital Italiano

location_facility: Hospital das Clinicas da Faculdade de Medinina de Univeridade

location_facility: Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Hematology Oncology Associates of Rockland

location_facility: Stockton Hematology Oncology Medical Group, Inc.

location_facility: Fairfax-Northern Virginia Hematology Oncology, PC

location_facility: Instituto Nacional de Cancerologia (INCAN)

location_facility: Instituto Especializado Alexander Fleming

location_facility: Thunder Bay Regional Health Science Center Northwestern Ontario Regional Center

location_facility: Desert Hematology Oncology Medical Group, Inc

location_facility: Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute

location_facility: Cape Breton Districk Health Authority Cancer Care

location_facility: The Center for Cancer and Blood Disorders

location_facility: Cancer Therapy & Research Center, Institute for Drug Development

location_facility: Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)

location_facility: University of Miami, Sylvester Comprehensive Cancer Center

location_facility: Big Sky Oncology, Sletten Cancer Institute

location_facility: St. Vincents Comprehensive Cancer Center

title: A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.

summary:
The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.

A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.


title: A Double Blind, Randomised, 3-Arm Parallel Group, Multicentre, 8-Week, Phase III Study to Assess Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) /HCT 32/12.5mg and 32/25mg vs. CC 32mg Alone in Patients With Inadequate BP Control on Monotherapy With CC 32mg

summary: In this study it is intended to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg and the combination of candesartan 32 mg and HCT 12.5 mg to that of candesartan 32 mg alone in patients whose blood pressure is not well controlled on candesartan 32 mg monotherapy. The Primary Objectives are to compare sitting BP lowering effect of candesartan/HCT 32/25 mg and candesartan/HCT 32/12.5 mg with that of candesartan 32 mg, respectively.

lead_sponsor: AstraZeneca

location_country:
Sweden
Former Serbia and Montenegro
Netherlands
France
Poland
Lithuania
Estonia
Denmark
Germany
United Kingdom
Ukraine

location_facility:
Research SIte
Research Site


intervention_type: Other

lead_sponsor: Celgene

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
Spain
Croatia
France
Lithuania
Poland
Slovakia
Norway
Argentina
Moldova, Republic of
Canada
Slovenia
Korea, Republic of
South Africa
Sweden
Saudi Arabia
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Serbia
Mexico
Czechia
Israel
Georgia
Belarus
Turkey
Latvia

location_facility: Institute of Gastroenterology and Hepatology at Ha'Emek Medical Center

location_facility: Atlanta Center For Gastroenterology, P.C.

location_facility: Polish Mother's Memorial Hospital - Research Institute

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Beaujon

location_facility: City Clinical Hospital No 31 - St. Petersburg

location_facility: Mid America Gastrointestinal Consultants

location_facility: Dr. Carol Davila Central Military Emergency Clinical Hospital

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

location_facility: City Clinical Hospital n.a. V.M. Buyanov

location_facility: Krajská nemocnice Pardubice, Kožní oddelení

location_facility: JSC Evex Medical Corporation - Oncology Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: Harvard Medical School - Boston Children's Hospital

location_facility: Azienda Socio Sanitaria Territoriale (ASST) di Monza

location_facility: Joint Venture Company Diagnostic Center, Bioterm Ltd.

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Clinical Research Center Early-Phase Research Facility

location_facility: Johann Wolfgang Goethe University Hospital

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Sart Tilman Hospital Department of Gastroenterology and Hepatology

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Integrated University Hospital Santa Maria della Misericordia of Udine

location_facility: Non-Public Healthcare Facility Allmedica Clinical Trials

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: University Hospital Marques de Valdecilla (HUMV)

location_facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

location_facility: Sultan Abdulhamid Han Egitim ve Arastirma Hastanesi

location_facility: Practice for Gastroenterology and Internal Medicine

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: Humanitas Research Hospital - Humanitas Mirasole S.p.A

location_facility: Bucharest University Emergency Hospital, Department of Internal Medicine II

location_facility: Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

location_facility: Vilnius University Hospital Santariskes Clinics

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: University Hospital Puerta de Hierro Majadajonda

location_facility: The Seventh Medical Center of PLA General Hospital

location_facility: Bezmialem Foundation University Medical Faculty

location_facility: Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra

location_facility: Soukroma Gastroenterologicka ambulance a endoskopie

location_facility: Jan Mikulicz Radecki University Hospital

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V.

location_facility: Research Associates of South Florida LLC

location_facility: DiGiovanna Institute for Medical Education And Research

location_facility: Bat Yamon Medical Center, Clalit Medical Services

location_facility: Institut klinicke a experimentalni mediciny

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

location_facility: Moscow Clinical Scientific and Practical Center

location_facility: Universitaetsklinikum Charite - Ruppiner Kliniken GmbH

location_facility: A.N. Ryzhikh State Research Center for Coloproctology

location_facility: Queen Fabiola Children's University Hospital

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

location_facility: University Hospital Centre Zagreb, Clinic of Internal Diseases

location_facility: Universidad Nacional De Rosario - Hospital Provincial Del Centenario

location_facility: Instituto Tecnológico y de Estudios Superiores de Monterrey

location_facility: N.N. Burdenko Penza Regional Clinical Hospital

location_facility: Children's Center for Digestive Healthcare

location_facility: Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: General Hospital Djordje Jovanovic Zrenjanin

location_facility: Advance Clinical Research - Dayton Internal Medicine

location_facility: JSC Evex Medical Corporation - Telavi Referral Hospital

location_facility: Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Primorsky Regional Clinical Hospital No.1

location_facility: TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC

location_facility: Helsicore - Israeli Georgian Medical Research Clinic

location_facility: Interdisciplinary Crohn Colitis Center Rhein Main

location_facility: Semmelweis Egyetem - Altalanos Orvostudomanyi Kar

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: ACIBADEM City Clinic Medical Center Bregalnitsa

location_facility: Csongrad County Dr. Bugyi Istvan Hospital

location_facility: JSC Evex Medical Corporation - Batumi Referral Hospital

location_facility: Maternal Pediatric and Adolescent Healthcare Centre

location_facility: Centro de Investigacion Clinica Acelerada (CICA) S.C.

location_facility: Univerisity Polyclinic Foundation Agostino Gemelli

location_facility: The Center for Gastrointestinal Disorders

location_facility: H-T. Medical Center Sp. z o.o. LLC Limited Partnership

location_facility: Ok Clinic Medical Center within International Institute of Clinical Trials, LLC

location_facility: Republican Clinical Hospital, Department of Colorectal Surgery

location_facility: Washington University School of Medicine

location_facility: Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat

location_facility: Gastroenterology Associates Of Central Georgia LLC

location_facility: Maggiore Polyclinic Hospital, IRCCS Ca' Granda

location_facility: Clinical Hospital Center - Dr. Dragisa Misovic-Dedinje

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: The Second Affiliated Hospital Of Zhengzhou University

location_facility: Connecticut Clinical Research Foundation

location_facility: Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe

location_facility: P. Stradins Clinical University Hospital

location_facility: Henry Ford Medical Center - New Center One

location_facility: Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine

location_facility: Harry Perkins Medical Research Institute, Fiona Stanley Hospital

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

location_facility: Riga East Clinical University Hospital clinic Gailezers

location_facility: "Sfanta Treime" Clinical Municipal Hospital

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine

location_facility: John Hunter Hospital and Hunter Medical Research Institute

location_facility: Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University

location_facility: UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit

location_facility: Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE

location_facility: General Hospital "Prim.dr. Abdulah Nakas"

location_facility: Odesa Regional Clinical Hospital Regional Gastroenterology Center Surgery Department

location_facility: Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia

location_facility: CHU Nantes University Hospital - Hotel Dieu Hospital

location_facility: Clinical Hospital Center Zvezdara Clinic of Internal Diseases

location_facility: Cancer Care Associates of OK-N PorterAvenue

location_facility: University Clinical Hospital of Valencia

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Multidisciplinary Clinic of the St. Nicholas, LLC

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: VA Northern California Health Care System

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: West Edmonton Gastroenterology Consultants

location_facility: Toronto Digestive Disease Associates Inc

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: V.T. Zaitsev Institute of General and Emergency Surgery

location_facility: Southern California Research Institute Medical Group, Inc.

location_facility: Ural State Medical Academy - Medical Association Novaya Bolnitsa

location_facility: University of Florida Health Endocrinology - Medical Specialties - Medical Plaza

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

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: Allergy, Asthma and Immunology Center, PC

location_facility: Craiova County Emergency Clinical Hospital

location_facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg

location_facility: Center of Diagnosis and Treatment Provita

location_facility: Multiprofile Hospital for Active Treatment Medline

location_facility: Seoul National University Bundang Hospital

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Scientific Research Institute of Physiology and Basic Medicine

location_facility: Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi

location_facility: BIK-KYIV Ukrainian German Gastroenterology Center

location_facility: Diagnostic-Consultative Center Sveta Anna

location_facility: University Hospital Germans Trias i Pujol

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Samara Station Railway Clinical Hospital under OAO Russian Railways

location_facility: Kindred Medical Institute for Clinical Trials, LLC

location_facility: Carolinas HealthCare System Digestive Health

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Gastroenterological Special Practice at Wittenbergplatz

location_facility: Zhangzhou Municipal Hospital of Fujian Province

location_facility: University of California at San Francisco

location_facility: University Hospital of Girona Dr. Josep Trueta

location_facility: S.V. Beliaev Kemerovo Regional Clinical Hospital

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: University of Pennsylvania Cancer Center

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Medical Scientific Manufacturing Association Dvizheniye Clinic

location_facility: Diagnostic and Consulting Center Alexandrovska

location_facility: Salve Limited Liability Company Limited Partnership, Outpatient Clinic

location_facility: Medical Center of Far-Eastern Federal University

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

location_facility: Advanced Research for Health Improvement

location_facility: SPb SBIH City Hospital of Saint Martyr Elizaveta

location_facility: Helsinki University Central Hospital (HUCH)

location_facility: University of Calgary Health - The Gastrointestinal Research Group (GIRG)

location_facility: Public City Clinical Hospital of Emergency Medical Care

location_facility: Kornel Gibinski Independent Public Central Clinical Hospital in Katowice

location_facility: Budget Institution of the Khanty-Mansiysk Autonomous Okrug - Ugra Surgut Regional Clinical Hospital

location_facility: Saint-Etienne University Hospital Center

location_facility: Biopharma Informatic Inc. Research Center

location_facility: Clinical Center of Vojvodina, Clinic of Gastroenterology and Hepatology

location_facility: Medical Center Medical Clinic Blagomed LLC

location_facility: Brigham and Women's Hospital - Crohn's and Colitis Center

location_facility: Ohio State University Wexner Medical Center

location_facility: London Health Sciences Centre, University Hospital

location_facility: Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Sotiria Chest Diseases Hospital of Athens

location_facility: St. John Paul 2nd Municipal Hospital in Elblag

location_facility: Korea University Medical Center - Korea University Ansan Hospital

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office

location_facility: Targu Mures County Emergency Clinical Hospital

location_facility: "Sf. Arhanghel Mihail" Municipal Clinical Hospital

location_facility: Federal Siberian Research and Clinical Center

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Dnipropetrovsk II Mechnykov Regional Clinical Hospital Surgery Department 2

location_facility: I.I. Mechnikov North-Western State Medical University

location_facility: Hospital Christus Muquerza del Parque S.A. de C.V.

location_facility: Euromed Multi-Specialty Center for Contemporary Medicine LLC

location_facility: Palo Alto Center-Palo Alto Medical Foundation Research Institute

location_facility: University Hospital of the Canary Islands (HUC) La Laguna

location_facility: Ternopil City Public Emergency Medical Care Hospital

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

location_facility: University Polyclinic Hospital G. Martino

location_facility: Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases

location_facility: General Hospital of Thessaloniki Hippokration

location_facility: LTD Academician N.Kipshidze Central University Clinic

location_facility: Provincial Specialist Hospital in Olsztyn

location_facility: G.G. Kuvatov Republican Clinical Hospital

location_facility: Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery

location_facility: Centro Regiomontano de Estudios Clinicos Roma SC.

location_facility: Vinnytsia M.I. Pyrohov Regional Clinical Hospital

location_facility: Endoterapia PFG LLC, Endotherapy PFG Outpatient Clinic Branch No 1

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: World of the Health Inc. General Hospital Rimavska Sobota

location_facility: Military Medical Academy, Clinic of Gastroenterology and Hepatology

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: Cotton ONeil Clinical Research Center Digestive Health

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: State Unitary Enterprise Passengeravtotrans

type: Registry Identifier

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

summary: This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.


title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)

acronym: CANTATA

summary: This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma with a clear cell component.

ipd_sharing: No

lead_sponsor: Calithera Biosciences, Inc

location_country:
Italy
United States
France
Australia
New Zealand
Spain
Germany
United Kingdom

location_facility: Sarah Cannon Research Institute UK Limited

location_facility: Medical University Heidelberg, NCT (National Center for Tumour Diseases), Medical Oncology

location_facility: Institut Català d'Oncologia (ICO) L'Hospitalet

location_facility: Northwestern Medicine Cancer Center Warrenville

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: University of Mississippi Medical Center

location_facility: Azienda Ospedaliero Universitaria San Luigi Gonzaga

location_facility: IUCTO Bureau des Essais Cliniques (Institut Claudius Regaud)

location_facility: Salinas Valley Memorial Healthcare System

location_facility: Hôpital Européen Georges-Pompidou (HEGP)

location_facility: St. Luke's Mountain States Tumor Institute

location_facility: Georgia Cancer Center at Augusta University

location_facility: Southern Highlands Private Hospital (Cancer Centre)

location_facility: Universitätsklinikum Essen (AöR) Westdeutsches Tumorzentrum

location_facility: Hospital Universitario Virgen de Macarena

location_facility: University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: St. Bartholomew's Hospital, Barts Health NHS Trust

location_facility: S.C. Oncologia - ASST Cremona P.O. Ospedale di Cremona

location_facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Technischen Universitat München - Urologische Klinik

location_facility: Institut Paoli-Calmettes Service d'Urologie

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Institut de Cancérologie de l'Ouest (ICO) - Centre René Gauducheau

location_facility: North Shore Hematology Oncology Associates PC dba NY Cancer and Blood Specialists

location_facility: Institut Gustave Roussy - Le département de Medecine oncologique

location_facility: Penrose Cancer Center, Research Department

location_facility: Unità Operativa (UO) di Oncologia Medica - ICS Maugeri

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik

location_facility: Nottingham University Hospitals NHS Trust - City Hospital Campus

location_facility: Istituto Europeo di Oncologia - Divisione di Oncologia Medica Urogenitale e Cervico Facciale

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center

location_facility: Charité Universitätsmedizin Berlin, Dept. of Interdisciplinary Urology

location_facility: INTEGRIS Cancer Institute of Oklahoma Proton Campus

location_facility: Mater Misericordiae Limited - Division of Cancer Services

location_facility: Universitätsklinikum Tübingen, Klinik für Urologie

location_facility: Hospital Universitari VHIO - Vall d'Hebron Departamento de Oncologia

location_facility: Fundación Instituto Valencia d'Oncología (IVO)

location_facility: Presidio Ospedaliero Antonio Perrino - U.O.C. Oncologia Medica

location_facility: U.O.C. ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo

location_facility: HealthPartners Institute, Regions Cancer Care Center

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: Institut de Cancérologie de Montpellier (ICM)

location_facility: Centre hospitalier universitaire (CHU) Henri-Mondor

location_facility: U.O. Oncologia Ospedale degli Infermi - Dipartimento di Oncologia ed Ematologia

location_facility: The Center for Cancer and Blood Disorders

location_facility: AMITA Health Cancer Institute & Outpatient Center

location_facility: CHU de Strasbourg (Les Hôpitaux Universitaires de Strasbourg)

location_facility: University of Modena and Reggio Emilia (Azienda Ospedaliera-Universitaria Policlinico Modena)

location_facility: El Hospital Clínic i Provincial de Barcelona (HCPB)

location_facility: Centre hospitalier régional universitaire (CHRU) de Besançon - Jean-Minjoz

location_facility: H.Lee Moffitt Cancer & Research Institute (Moffitt Cancer Center)

location_facility: Centro Integral Oncologico Clara Campal (CIOCC) HM


title: Phase 3 Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Reltecimod as Compared to Placebo in Addition to Standard of Care in Patients With Sepsis-associated Acute Kidney Injury (SA-AKI)

summary: Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.

status: Terminated

lead_sponsor: Atox Bio Ltd

location_country:
United States
France

location_facility: University of Texas Health Science Center at San Antonio

location_facility: University of California, Davis Medical Center

location_facility: The Pennsylvania State University and The Milton S. Hershey Medical Center

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Cincinnati Medical Center (UCMC)

location_facility: Erie County Medical Center-Affliate of SUNYat Buffalo

location_facility: University of Minnesota Medical Center-Fairview

status_simplified: Unknown