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 | Helen Daykin | hdaykin@adelaidecancercentre.com.au | 08 8292 2240 | Recruitment on Hold |