CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,101 enrolled
Drug / intervention
Ipatasertib +3 moredrug
Likely dose
Ipatasertib 400 mgfrom 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/NCT03072238
NCT03072238Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer

Hoffmann-La Roche·interventional·Posted Mar 7, 2017·Updated Jun 6, 2025

In Brief

A Phase 3 clinical trial evaluating Ipatasertib, Abiraterone, and 2 other interventions for Metastatic Prostate Cancer. Completed, enrolled 1,101 participants across 176 sites in 26 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Prostate Cancer
CountriesAustralia, Austria, Belgium, Brazil, Canada, China, Costa Rica, Denmark, France, Greece, Hungary, Ireland, Israel, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 7, 2017
Enrollment StartJun 30, 2017
Primary CompletionMar 16, 2020
Study CompletionApr 24, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.3 years ago

Interventions

Ipatasertibdrug

Oral tablets, 400 mg, given once daily (QD) beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.

Abirateronedrug

Oral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water.

Placebodrug

Oral tablets (matched to ipatasertib appearance), given QD beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.

Prednisone/Prednisolonedrug

Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity.