NCT03072238

Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,101 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	Ipatasertib	Oral tablets, 400 mg, given once daily (QD) beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.
DRUG	Abiraterone	Oral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water.
DRUG	Placebo	Oral tablets (matched to ipatasertib appearance), given QD beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.
DRUG	Prednisone/Prednisolone	Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity.

Timeline

• Start date: 2017-06-30
• Primary completion: 2020-03-16
• Completion: 2024-04-24
• First posted: 2017-03-07
• Last updated: 2025-06-06
• Results posted: 2023-04-10

Locations

176 sites across 26 countries: United States, Australia, 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

Regulatory

• FDA-regulated drug study