drugset / Trial / NCT03840200

A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.

NCT03840200

Phase 1 Completed 51 enrolled Hoffmann-La Roche
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a study in participants with advanced breast, ovarian, or prostate cancer to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of ipatasertib in combination with rucaparib. The study consists of two parts: a Dose-Escalation Phase (Part 1) in participants with previously treated advanced breast cancer, ovarian cancer, or prostate cancer and a Dose-Expansion Phase (Part 2) in participants with advanced prostate cancer who have had at least one line of prior therapy with second-generation androgen-receptor (AR)-targeted agents (e.g., abiraterone, enzalutamide, apalutamide).

Timeline

Start
2019-06-12
Primary completion
2021-12-07
Completion
2022-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipatasertib Small molecule 300 mg Oral
Subject Ipatasertib Small molecule 400 mg Oral
Subject Rucaparib Small molecule 400 mg Oral
Subject Rucaparib Small molecule 600 mg Oral