CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 51 enrolled
Drug / intervention
Ipatasertib +1 moredrug
Likely dose
Not stated in 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/NCT03840200
NCT03840200Phase 1Completed

A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Rucaparib in Patients With Advanced Breast, Ovarian, or Prostate Cancer

Hoffmann-La Roche·interventional·Posted Feb 15, 2019·Updated Oct 30, 2023

In Brief

A Phase 1 clinical trial evaluating Ipatasertib and Rucaparib for Breast Cancer and 2 related conditions. Completed, enrolled 51 participants across 17 sites in 5 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Italy, South Korea, Spain, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedFeb 15, 2019
Enrollment StartJun 12, 2019
Primary CompletionDec 7, 2021
Study CompletionJan 4, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.4 years ago

Interventions

Ipatasertibdrug

Ipatasertib will be administered orally.

Rucaparibdrug

Rucaparib will be administered orally.