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Spots Global Cancer Trial Database for ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

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Trial Identification

Brief Title: ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

Official Title: ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL): A Phase 3 Multicenter, Randomized Study of Rucaparib Versus Chemotherapy in Patients With Relapsed, BRCA Mutant, High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Study ID: NCT02855944

Study Description

Brief Summary: The purpose of this study is to determine how patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy.

Detailed Description: Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination (HR) DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutations. While PARP inhibitors have demonstrated consistent robust clinical activity in patients with relapsed ovarian cancer associated with HRD, prospective studies evaluating efficacy and safety of PARPi versus standard of care chemotherapy have been limited. The primary purpose of this Phase 3 study is to compare the efficacy and safety of rucaparib versus chemotherapy as treatment for relapsed ovarian cancer in patients with a deleterious BRCA1/2 mutation in their tumor.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Rocky Mountain Cancer Center, Denver, Colorado, United States

Augusta University, Augusta, Georgia, United States

Hospital Haroldo Juacaba Instituto do Cancer do Ceara, Fortaleza, Ceara, Brazil

Instituto de Oncologia do Parana (IOP), Curitiba, Parana, Brazil

União Brasileira de Educação e Assistência / Hospital São Lucas da PUCRS, Porto Alegre, RIO Grande DO SUL, Brazil

CEPON-Centro de pesquisas Oncologicas, Florianópolis, Santa Catarina, Brazil

Hospital do Cancer de Barretos, Barretos, SAO Paulo, Brazil

Instituto Nacional de Câncer Hospital do Câncer II, Rio de Janeiro, , Brazil

Hospital Pérola Byington - Centro de Referência da Saúde da Mulher, Sao Paulo, , Brazil

Hospital São Camilo, Sao Paulo, , Brazil

Tom Baker Cancer Center, Calgary, Alberta, Canada

The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada

Princess Margaret Hospital, Toronto, Ontario, Canada

Centre Hospitalier de L'Universite de Montreal (CHUM), Montreal, Quebec, Canada

CIUSSS de l'Estrie CHUS, Sherbrooke, Quebec, Canada

Masarykuv Onkologicky Ustav, Oddeleni komplexni klinicke onkologie, Brno, Jihormoravsky KRAJ, Czechia

Fakultni Nemocnice v Motole, Praha 5, Praha, Czechia

Fakultní Nemocnice Ostrava, Ostrava, , Czechia

Všeobecná Fakultní Nemocnice v Praze, Praha, , Czechia

Debreceni Egyetem Klinikai Központ, Debrecen, Hajdu-bihar, Hungary

Országos Onkológiai Intézet, Budapest, , Hungary

Carmel Medical Center, Haifa, , Israel

Edith Wolfson Medical Center, Holon, , Israel

Hadassah Medical Organization, Jerusalem, , Israel

Rabin Medical Center, Petach-Tikva, , Israel

Chaim Sheba Medical Center, Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center, Oncology Dept., Tel Aviv, , Israel

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna, , Italy

Istituto per la Ricerca e la Cura del Cancro Istituto di Candiolo, Candiolo, , Italy

AO per l'emergenza Cannizzaro, Catania, , Italy

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy

Istituto Europeo di Oncologia, Milano, , Italy

Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, , Italy

Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica, Napoli, , Italy

Fondazione Policlinico Universitario Agostino Gemelli, Roma, , Italy

Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna Sp z o.o., Grzybnica, West Pomeranian Voivodeship, Poland

Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie, Bialystok, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, , Poland

Wojewodzki Szpital Specjalistyczny w Olsztynie, Olsztyn, , Poland

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna, Poznan, , Poland

Pomorska Akademia Medyczna w Szczecinie, Samodzielny Publiczny Szpital Kliniczny Nr 2, Szczecin, , Poland

Arkhangelsk Clinical Oncological Dispensary, Arkhangelsk, , Russian Federation

Kursk Regional Oncologic Dispensary, Kursk, , Russian Federation

Moscow Clinical Scientific and Practical Center of Moscow Healthcare Department, Moscow, , Russian Federation

Omsk Region Clinical Oncologic Dispensary, Omsk, , Russian Federation

Pyatigorsk Oncological Dispensary, Pyatigorsk, , Russian Federation

Ryazan Regional Clinical Oncology Dispensary, Ryazan, , Russian Federation

Pavlov First Saint-Petersburg State Medical University, Saint Petersburg, , Russian Federation

State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region, Saint Petersburg, , Russian Federation

Saint Petersburg City Oncological Dispensary, Saint-Petersburg, , Russian Federation

Republican oncological dispensary of Republic of Mordovia, Saransk, , Russian Federation

State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region, Sochi, , Russian Federation

Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan, Ufa, , Russian Federation

Hospital Duran i Reynals, Barcelona, , Spain

Hospital Universitari Vall DHebron, Barcelona, , Spain

Hospital Universitari de Girona Doctor Josep Trueta, Girona, , Spain

Centro Oncologico Regional de Galicia, La Coruna, , Spain

Hospital Clinico San Carlos, Madrid, , Spain

Hospital Universitario Ramón y Cajal, Madrid, , Spain

MD Anderson Cancer Center, Madrid, , Spain

Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz, Madrid, , Spain

Dnipropetrovsk City Multifield Clinical Hospital Number 4, Dnipropetrovsk, , Ukraine

National Cancer Institute of the Ministry of Health of Ukraine, Kyiv, , Ukraine

Volyn Regional Oncology Dispensary, Lutsk, , Ukraine

Lviv Regional Oncology Dispensary, Lviv, , Ukraine

Sumy Regional Oncology Center, Sumy, , Ukraine

Zakarpattya Regional Clinical Oncological Dispensary, Uzhgorod, , Ukraine

The Christie NHS Foundation Trust - Clinical Trial Pharmacy, Manchester, England, United Kingdom

The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom

Cambridge University Hospitals NHS Foundation Trust, Cambridge, , United Kingdom

Velindre NHS Trust, Cardiff, , United Kingdom

University Hospital of Coventry and Warwickshire NHS Trust, Coventry, , United Kingdom

Derby Teaching Hospital NHS Foundation Trust, Derby, , United Kingdom

NHS Greater Glasgow and Clyde, Glasgow, , United Kingdom

University College London Hospitals, London, , United Kingdom

East and North Hertfordshire NHS Trust, Middlesex, , United Kingdom

Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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