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

Completed · Phase 3

Conditions studied: Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT02855944

Run by

pharmaand GmbH

People needed

349

Starts

2017-03-01

Expected to finish

2022-09-16

Last updated by the study team

2023-06-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Augusta University — Augusta, Georgia, United States
• Hospital Haroldo Juacaba Instituto do Cancer do Ceara — Fortaleza, Ceará, Brazil
• Instituto de Oncologia do Parana (IOP) — Curitiba, Paraná, 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, São Paulo, Brazil
• Instituto Nacional de Câncer Hospital do Câncer II — Rio de Janeiro, Brazil
• Hospital Pérola Byington - Centro de Referência da Saúde da Mulher — São Paulo, Brazil
• Hospital São Camilo — São 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 — Prague, Prague, Czechia
• Fakultní Nemocnice Ostrava — Ostrava, Czechia
• Všeobecná Fakultní Nemocnice v Praze — Prague, Czechia
• Debreceni Egyetem Klinikai Központ — Debrecen, Hajdú-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 — Petah Tikva, Israel
• Rocky Mountain Cancer Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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