Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
Public ClinicalTrials.gov record NCT01485861. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and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 identification
- NCT ID
- NCT01485861
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 298 participants
Conditions and interventions
Conditions
Interventions
- Abiraterone Drug
- Apitolisib Drug
- Ipatasertib Drug
- Placebo Drug
- Prednisone Drug
- Prednisolone Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 11, 2012 (Actual)
- Primary completion
- Sep 1, 2015 (Actual)
- Completion
- Aug 31, 2022 (Actual)
- Last update posted
- Sep 14, 2023
2012 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Research Institute ? Bisgrove | Scottsdale | Arizona | 85258 | — |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | — |
| Florida Cancer Specialists - Fort Myers (New Hampshire Ct) | Fort Myers | Florida | 33901-8101 | — |
| Florida Cancer Specialists; Sarasota | Sarasota | Florida | 34232 | — |
| Kaiser Permanente Medical Ctr | Honolulu | Hawaii | 96819 | — |
| Johns Hopkins Univ; Bunting Blaustein Cancer Center | Baltimore | Maryland | 21231 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Urology Cancer Center & GU Research Network | Omaha | Nebraska | 68130 | — |
| New York Cancer and Blood Specialists - Setauket Medical Oncology | East Setauket | New York | 11733 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Sarah Cannon Cancer Center - Tennessee Oncology, Pllc | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01485861, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 14, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01485861 live on ClinicalTrials.gov.