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Clinical trial

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

ID
Name
CO-338-043
Description
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.
Trial arms
Trial start
2017-03-01
Estimated PCD
2020-12-03
Trial end
2022-09-16
Status
Completed
Phase
Early phase I
Treatment
Chemotherapy
Chemotherapy will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.
Arms:
Chemotherapy
Other names:
Cisplatin, carboplatin, carboplatin/paclitaxel, carboplatin/gemcitabine, paclitaxel
Rucaparib
Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice a day
Arms:
Rucaparib
Other names:
CO-338, AG 14699, PF 01367338, Rubraca
Size
349
Primary endpoint
Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population)
Assessments every 8 weeks from Cycle 1 Day 1 (C1D1) until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (ITT Population)
Assessments every 8 weeks from C1D1 until disease progression, death, or initiation of subsequent treatment. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3.5 years.
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 349, 'type': 'ACTUAL'}}
Updated at
2023-06-09

1 organization

2 products

3 indications

Organization
Pharmaand
Product
Chemotherapy
Indication
Ovarian Cancer
Indication
Fallopian tube cancer
Indication
Peritoneal Cancer
Product
Rucaparib