CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 298 enrolled
Drug / intervention
Abiraterone +5 moredrug
Likely dose
Not stated in 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/NCT01485861
NCT01485861Phase 2Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted Dec 6, 2011·Updated Sep 14, 2023

In Brief

A Phase 2 clinical trial evaluating Abiraterone, Apitolisib, and 4 other interventions for Prostate Cancer. Completed, enrolled 298 participants across 59 sites in 9 countries.

Detailed 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in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCzechia, France, Greece, Italy, Netherlands, Romania, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2011
Enrollment StartJan 11, 2012
Primary CompletionSep 1, 2015
Study CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.6 years ago

Interventions

Abirateronedrug

Orally once daily

Apitolisibdrug

Orally once daily

Ipatasertibdrug

Orally once daily

Placebodrug

Orally once daily

Prednisonedrug

Orally bid

Prednisolonedrug

Orally bid