CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 136 enrolled
Drug / intervention
Rucaparibdrug
Likely dose
Rucaparib 240 mLfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01482715
NCT01482715Phase 2Completed
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A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With gBRCA Mutation Ovarian Cancer or Other Solid Tumor

pharmaand GmbH·interventional·Posted Nov 30, 2011·Updated Jun 9, 2023

In Brief

A Phase 2 clinical trial evaluating Rucaparib for Ovarian Cancer and 3 related conditions. Completed, enrolled 136 participants across 16 sites in 5 countries.

Detailed Summary

Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate the safety of different doses and dosing regimens of oral rucaparib administered daily to patients with solid tumors. Part 2A (Completed Enrollment) and Part 2B (Completed Enrollment) - The purpose of the second part of the study is to determine the safety and clinical activity of the RP2D of oral rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or somatic). Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Advanced Solid Tumor With Evidence of Germline or Somatic BRCA
CountriesCanada, Israel, Spain, United Kingdom, United States
CollaboratorsFoundation Medicine

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2011
Enrollment StartNov 1, 2011
Primary CompletionMar 1, 2019
Study CompletionMay 1, 2019
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 14.6 years ago

Interventions

Rucaparibdrug

Oral tablets administered daily with 8 oz (240 mL) of water on an empty stomach or with food; 21-day cycles of treatment. In Part 1, the initial dose level is 40 mg/day (once a day); doses and dosing frequency(e.g. twice a day or three times a day) will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. Patients enrolled in Part 2 and Part 3 will receive the RP2D for continuous 21-day treatment cycles until disease progression.