CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 564 enrolled
Drug / intervention
Rucaparib +1 moredrug
Likely dose
Rucaparib 240 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01968213
NCT01968213Phase 3Completed
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A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer ( ARIEL3 )

pharmaand GmbH·interventional·Posted Oct 23, 2013·Updated Jun 9, 2023

In Brief

A Phase 3 clinical trial evaluating Rucaparib and Placebo for Ovarian Cancer and 2 related conditions. Completed, enrolled 564 participants across 96 sites in 11 countries.

Detailed Summary

Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
CountriesAustralia, Belgium, Canada, France, Germany, Israel, Italy, New Zealand, Spain, United Kingdom, United States
CollaboratorsFoundation Medicine, Myriad Genetics, Inc.

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 23, 2013
Enrollment StartApr 7, 2014
Primary CompletionApr 1, 2017
Study CompletionJul 7, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.7 years ago

Interventions

Rucaparibdrug

Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.

Placebodrug

Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.