NCT01385293

BKM120 in Metastatic Castration-resistant Prostate Cancer

Phase II Study of BKM120 in Men With Metastatic Castration-Resistant Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Andrew J. Armstrong, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of the study drug, BKM120. The study drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This protein is found in normal cells and in cancer cells, but often in many cancer cells this protein is overactive. Inhibiting the protein may slow the growth of prostate cancer but this has not been tested yet in men with prostate cancer.

Detailed description

This is an open label, single arm phase II study of BKM120 in men with metastatic castration resistant prostate cancer (CRPC) who have progressed on or following completion of docetaxel-based chemotherapy. Prior progression on cabazitaxel, provenge, abiraterone, or enzalutamide (MDV3100) is also permitted. Patients must have baseline evaluations performed prior to the first dose of study drug and must meet all inclusion and exclusion criteria. Results of the baseline evaluations, which assure that all inclusion and exclusion criteria have been satisfied, must be reviewed by the Principal Investigator or his/her designee prior to enrollment of that patient. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the patient prior to protocol-specific screening tests. The following criteria apply to all patients enrolled onto the study unless otherwise specified.

Conditions

• Prostate Cancer
• Metastatic (Spread to Other Areas of the Body)

Interventions

Type	Name	Description
DRUG	BKM120	BKM120 at the maximum tolerated dose (MTD) of 100mg orally daily

Timeline

• Start date: 2011-08-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2011-06-30
• Last updated: 2017-05-19
• Results posted: 2017-04-07

Locations

3 sites across 1 country: United States