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

COMPLETEDPHASE1/PHASE2

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

NCT01485861•Genentech, Inc.

View on ClinicalTrials.gov

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in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and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

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been previously treated with docetaxel-based therapy and has progressed during treatment of at least one hormonal therapy(prior docetaxel is not required for the safety cohort)
•Two rising PSA levels greater than or equal to (\>/=) 2 ng/mL measured \>/= 1 week apart or radiographic evidence of disease progression in soft tissue or bone
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
•Adequate hematologic and organ function
•Documented willingness to use an effective means of contraception
•Safety cohort only: agreement to use CGM for first cycle of treatment

Exclusion Criteria

•New York Heart Association Class III or IV heart failure or Left ventricular ejection fraction \< 50% or ventricular arrhythmia requiring medication
•Significant atherosclerotic disease, as evidenced by: unstable angina, history of myocardial infarction within 6 months prior to Day 1, or cerebrovascular accident within 6 months prior to Day 1
•Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs or active inflammatory disease which requires immunosuppressive therapy
•Clinically significant history of liver disease
•History of adrenal insufficiency or hyperaldosteronism
•Phase II only: Previous therapy for prostate cancer with 17 alpha-hydroxylase/C17,20-lyase inhibitors, including abiraterone
•Phase II only: Previous treatment for prostate cancer with Protein kinase B phosphatidylinositol 3 kinase and/or mammalian target of rapamycin inhibitors
•Need for chronic corticosteroid therapy of \>/= 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant

Locations (59)

HonorHealth Research Institute ? Bisgrove

Scottsdale, Arizona, United States

Pacific Hematology Oncology Associates

San Francisco, California, United States

Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

Fort Myers, Florida, United States

Florida Cancer Specialists; Sarasota

Sarasota, Florida, United States

Kaiser Permanente Medical Ctr

Honolulu, Hawaii, United States

Johns Hopkins Univ; Bunting Blaustein Cancer Center

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Urology Cancer Center & GU Research Network

Omaha, Nebraska, United States

New York Cancer and Blood Specialists - Setauket Medical Oncology

East Setauket, New York, United States

Weill Cornell Medical College

New York, New York, United States

Key Dates

Start Date

January 11, 2012

Primary Completion Date

September 1, 2015

Completion Date

August 31, 2022

Last Updated

September 14, 2023

Enrollment

298

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Abiraterone

DRUG

Apitolisib

DRUG

Ipatasertib

DRUG

Placebo

DRUG

Prednisone

DRUG

Prednisolone

DRUG

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC