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.
Keywords
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
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