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Enzalutamide and Metformin Hydrochloride in Treating Patients With Hormone-Resistant Prostate Cancer

NCT02339168 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-05-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Enzalutamide

Given PO

DRUG

Metformin Hydrochloride

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Medivation, Inc.

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Marc Dall'Era, MD · University of California, Davis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-22
Primary Completion
2024-10-15
Completion
2025-02-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02339168 on ClinicalTrials.gov