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

Part of paid clinical trials in Denver, Colorado.

Sponsor
pharmaand GmbH
Study ID
NCT02855944
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy — DRUG
    Chemotherapy will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.
  • Rucaparib — DRUG
    Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice a day

Study Details

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 Dates

Start date
Mar 1, 2017
Status verified
Jun 2023
Primary completion
Dec 3, 2020
Completion
Sep 16, 2022

Study Design

Enrollment
349 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rucaparib
    Drug: Oral rucaparib 600 mg BID (twice a day) Other Names: * CO-338 * PF 01367338 * AG 14699 * Rubraca
  • Active Comparator: Chemotherapy
    Monotherapy platinum (cisplatin or carboplatin) or platinum-based doublet chemotherapy (carboplatin/paclitaxel, carboplatin/gemcitabine, or cisplatin/gemcitabine administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision. Single agent paclitaxel will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.

Primary Outcome Measure

Investigator Assessed Progression-Free Survival (invPFS) by RECIST Version 1.1 for Rucaparib Versus Chemotherapy (Efficacy Population) [ Time Frame: 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. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rocky Mountain Cancer CenterDenverColorado80218-
Augusta UniversityAugustaGeorgia30912-

Find similar trials in Denver, CO

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Rocky Mountain Cancer Center· Denver, COAugusta University· Augusta, GA

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