NCT01485861

Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy

A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone	Orally once daily
DRUG	Apitolisib	Orally once daily
DRUG	Ipatasertib	Orally once daily
DRUG	Placebo	Orally once daily
DRUG	Prednisone	Orally bid
DRUG	Prednisolone	Orally bid

Timeline

• Start date: 2012-01-11
• Primary completion: 2015-09-01
• Completion: 2022-08-31
• First posted: 2011-12-06
• Last updated: 2023-09-14
• Results posted: 2023-09-14

Locations

59 sites across 9 countries: United States, Czechia, France, Greece, Italy, Netherlands, Romania, Spain, United Kingdom