ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
NCT02855944 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 349
Last updated 2023-06-09
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.
Conditions
- Ovarian Cancer
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
- Peritoneal Cancer
Interventions
- DRUG
-
Chemotherapy will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.
- DRUG
-
Rucaparib
Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice a day
Sponsors & Collaborators
- collaborator INDUSTRY
-
pharmaand GmbH
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-01
- Primary Completion
- 2020-12-03
- Completion
- 2022-09-16
- FDA Drug
- Yes
Countries
- United States
- Brazil
- Canada
- Czechia
- Hungary
- Israel
- Italy
- Poland
- Russia
- Spain
- Ukraine
- United Kingdom
Study Locations
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