Enzalutamide + Metformin for Hormone-Resistant Prostate Cancer
Trial Summary
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of metformin hydrochloride when given together with enzalutamide in treating patients with prostate cancer that has not responded to previous treatment with hormones. Hormone therapy using enzalutamide may fight prostate cancer by lowering the amount of androgens the body makes and blocking the use of androgens by the tumor cells. Metformin hydrochloride, used for diabetes, may also help kill tumor cells. Giving enzalutamide together with metformin hydrochloride may kill more tumor cells.
Research Team
Marc Dall'Era, MD
Principal Investigator
University of California, Davis
Eligibility Criteria
Men with hormone-resistant prostate cancer, who have tried hormone therapy without success, can join this trial. They must have a certain level of health, including normal organ function and blood counts. Participants need to be on or willing to continue castration treatments if applicable and not have had certain prior medications for a specified period. Men must use two forms of birth control with their partners.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Enzalutamide
- Metformin Hydrochloride
Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Medivation, Inc.
Industry Sponsor
Dr. David Hung
Medivation, Inc.
Chief Executive Officer since 2003
MD from University of California, San Francisco; AB in Biology from Harvard College
Dr. Stephen M. Kelsey
Medivation, Inc.
Chief Medical Officer since 2013
MD from University of Birmingham
Astellas Pharma Inc
Industry Sponsor
Tadaaki Taniguchi
Astellas Pharma Inc
Chief Medical Officer since 2023
MD, PhD
Naoki Okamura
Astellas Pharma Inc
Chief Executive Officer since 2023
University of Tokyo, Faculty of Pharmacy