25 Participants Needed

Enzalutamide + Metformin for Hormone-Resistant Prostate Cancer

Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: University of California, Davis
Must be taking: Enzalutamide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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

MD

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

Estimated life expectancy >= 6 months
Ability to understand and the willingness to sign a written informed consent document
Total bilirubin within normal institutional limits
See 23 more

Exclusion Criteria

I do not have brain metastases.
I am not HIV-positive or not on antiretroviral therapy.
I haven't had radiotherapy in the last 2 weeks or recovered from its side effects.
See 10 more

Treatment Details

Interventions

  • Enzalutamide
  • Metformin Hydrochloride
Trial OverviewThe trial is testing the combination of Enzalutamide (a hormone therapy) and Metformin Hydrochloride (commonly used for diabetes) to see if they work better together in treating prostate cancer that's resistant to hormones. The study will determine the safest doses and observe how well patients respond.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: enzalutamide and metformin hydrochlorideExperimental Treatment2 Interventions
Patients receive enzalutamide PO QD and metformin hydrochloride PO BID. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇪🇺
Approved in European Union as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇨🇦
Approved in Canada as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇯🇵
Approved in Japan as Xtandi for:
  • 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

Trials
958
Recruited
4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Medivation, Inc.

Industry Sponsor

Trials
76
Recruited
11,200+

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

Trials
700
Recruited
236,000+
Headquarters
Tokyo, Japan
Top Products
- Xtandi (enzalutamide) for prostate cancer, - Xospata (gilteritinib) for AML, - Padcev (enfortumab vedotin) for bladder cancer, - Prograf (tacrolimus) for organ rejection prevention
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Tadaaki Taniguchi

Astellas Pharma Inc

Chief Medical Officer since 2023

MD, PhD

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Naoki Okamura

Astellas Pharma Inc

Chief Executive Officer since 2023

University of Tokyo, Faculty of Pharmacy