drugset / Trial / NCT03101280

A Combination Study of Rucaparib and Atezolizumab in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer

NCT03101280

Phase 1 Completed 29 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase Ib, open-label, non-randomized study in patients with previously treated advanced ovarian or endometrial cancer (Part 1) and platinum-sensitive ovarian cancer or triple-negative breast cancer (TNBC) (Part 2) to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of rucaparib in combination with atezolizumab. The study is conducted in 2 parts: a Dose-Finding Phase (Part 1) and a Dose-Expansion Phase (Part 2)

Timeline

Start
2017-04-27
Primary completion
2020-08-11
Completion
2020-08-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Rucaparib Small molecule 400 mg Oral
Subject Rucaparib Small molecule 600 mg Oral