Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Be 18 years of age at the time the informed consent form is signed
Have a histologically confirmed diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
Received ≥ 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment
Have biopsiable and evaluable disease. Note: biopsy is optional for patients known to harbor a BRCA1/2 mutation
Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses

Exclusion Criteria:

History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed >6 months prior and/or bone marrow transplant >2 years prior to first dose of rucaparib).
Prior treatment with any PARP inhibitor
Symptomatic and/or untreated central nervous system metastases
Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
Women who are pregnant or breast feeding
Hospitalization for bowel obstruction within 3 months prior to enrollment

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

349

Study ID:

NCT02855944

Recruitment Status:

Completed

Sponsor:

zr Pharma & GmbH

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There are 3 Locations for this study

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Rocky Mountain Cancer Center
Denver Colorado, 80218, United States
Augusta University
Augusta Georgia, 30912, 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 , 11547, 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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

349

Study ID:

NCT02855944

Recruitment Status:

Completed

Sponsor:


zr Pharma & GmbH

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