Acronym:
CO39303
ACTRN/NCT /ethics:
NCT03072238
Scientific title:
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
Summary of trial and patient characteristics
Cancer Type | Prostate | ||
---|---|---|---|
Trial Type | Treatment | ||
Phase | Phase III | Tumour Stream | Prostate |
Age Range | 18 years and older | Cancer Stage | Metastatic or Widespread |
Sex | Male | Anticipated Start Date | 2017-06-30 |
Molecular Target | Anticipated End Date | 2023-09-09 |
Cancer Type | Prostate |
---|---|
Trial Type | Treatment |
Phase | Phase III |
Age Range | 18 years and older |
Sex | Male |
Molecular Target | |
Tumour Stream | Prostate |
Cancer Stage | Metastatic or Widespread |
Anticipated Start Date | 2017-06-30 |
Anticipated End Date | 2023-09-09 |
Trial 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).
Lay Summary
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
Sponsor / Cooperative group
Roche
Participating Hospitals
Hospital | Clinical Trial Coordinator | Phone | Principal Investigator | Recruitment Status | |
---|---|---|---|---|---|
Ashford Cancer Centre Research | Sue Yeend | syeend@adelaidecancercentre.com.au | 08 8292 2240 | Completed |