BKM120+Abiraterone Acetate for Metastatic CRPC

Status: Recruiting
Phase: Phase 1
Diagnosis: Prostate Cancer
NCT ID: NCT01741753 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-121

 

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug, in this case an investigational drug combined with standard drug therapy. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and taht research doctors are trying to find out more about it. It also means that the FDA has not approved the drug for use in patients, including people with your type of cancer. BKM120 is a drug that inhibits the ability of tumors to grow and survive, which may lead to better outcomes in many types of cancer. Abiraterone acetate is a drug that is approved for the treatment of prostate cancer, and works by inhibiting an enzyme found in prostate tumor tissue. While taking abiraterone acetate, individuals must also take a glucocorticoid such as prednisone. Most patients with castrate-resistant prostate cancer will receive treatment with docetaxel, after which treatment with the combination of abiraterone and prednisone has been shown to be effective. Evidence has shown an interaction between the pathways through which BKM120 and abiraterone act on cancer. Therefore, it is thought that the treatment of castrate-resistant prostate cancer will be enhanced by combining BKM120 with abiraterone plus prednisone. The purpose of this study is to determine a safe dose for the combination of daily oral BKM120, abiraterone acetate, and prednisone in patients with castrate-resistant metastatic prostate cancer who have received prior treatment with docetaxel.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute

Overall PI:
Glenn Bubley, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically confirmed CRPC with metastatic bone disease - Castrate resistant disease - Life expectancy of at least 6 months - At least four weeks from previous treatment - At least four weeks since any major surgery or radiation therapy - Using highly effective contraception Exclusion Criteria: - Thromboembolism within past 6 months - History of diabetes - Prior therapy with abiraterone - Prior therapy with PI3K inhibitor - Alcohol or drug dependence currently or within past 6 months - Contraindications to biopsy, such as bleeding disorders - On anticoagulants such as warfarin or heparin - Active malignancy other than skin cancer or superficial bladder cancer - Untreated brain metastases - Acute or chronic liver, renal disease or pancreatitis - Mood disorders judged by the investigator to interfere with study participation - Active cardiac disease or history of cardiac dysfunction - Uncontrolled hypertension - Known HIV, Hepatitis B or C - Serious non-healing wound, ulcer or bone fracture - Known or suspected allergy to BKM120, abiraterone or prednisone - Impairment of GI function
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