Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-22 @ 11:23 PM
Study NCT ID:
NCT02339168
Status:
COMPLETED
Last Update Posted:
2025-05-01
First Post:
2015-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enzalutamide and Metformin Hydrochloride in Treating Patients With Hormone-Resistant Prostate Cancer
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
Enzalutamide and Metformin Combination Therapy to Overcome Autophagy Resistance in Castration Resistant Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of enzalutamide when given in combination with metformin (metformin hydrochloride) to patients with castration resistant prostate cancer (CRPC), where fewer than 33% of patients experienced dose limiting toxicity (DLT) attributable to the study regimen and to recommend a phase II dose for the combination.
SECONDARY OBJECTIVES:
I. To determine prostate-specific antigen (PSA) response in patients with CRPC with given enzalutamide in combination with metformin.
II. To determine PSA progression in patients with CRPC with given enzalutamide in combination with metformin.
III. To investigate the feasibility and safety of enzalutamide when given in combination with metformin hydrochloride to patients with CRPC.
IV. To obtain preliminary evidence of efficacy for this combination.
TERTIARY OBJECTIVES:
I. To collect computed tomography (CT)-guided biopsies of metastatic soft tissue or bone tumor tissue for analysis of androgen receptor (AR) gene signature as an integrated biomarker (University of California San Francisco \[UCSF\] to conduct analysis).
II. To collect serum samples for the measurement of PSA levels and bone re-absorption markers.
OUTLINE: This is a dose-escalation study of metformin hydrochloride.
Patients receive enzalutamide orally (PO) once daily (QD) and metformin hydrochloride PO twice daily (BID). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4, 8, and 12 weeks.
I. To determine the maximum tolerated dose (MTD) of enzalutamide when given in combination with metformin (metformin hydrochloride) to patients with castration resistant prostate cancer (CRPC), where fewer than 33% of patients experienced dose limiting toxicity (DLT) attributable to the study regimen and to recommend a phase II dose for the combination.
SECONDARY OBJECTIVES:
I. To determine prostate-specific antigen (PSA) response in patients with CRPC with given enzalutamide in combination with metformin.
II. To determine PSA progression in patients with CRPC with given enzalutamide in combination with metformin.
III. To investigate the feasibility and safety of enzalutamide when given in combination with metformin hydrochloride to patients with CRPC.
IV. To obtain preliminary evidence of efficacy for this combination.
TERTIARY OBJECTIVES:
I. To collect computed tomography (CT)-guided biopsies of metastatic soft tissue or bone tumor tissue for analysis of androgen receptor (AR) gene signature as an integrated biomarker (University of California San Francisco \[UCSF\] to conduct analysis).
II. To collect serum samples for the measurement of PSA levels and bone re-absorption markers.
OUTLINE: This is a dose-escalation study of metformin hydrochloride.
Patients receive enzalutamide orally (PO) once daily (QD) and metformin hydrochloride PO twice daily (BID). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4, 8, and 12 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UCDCC#243 | OTHER | UC Davis UCDCC#243 | View | |
| UCDCC#243 | OTHER | University of California Davis Comprehensive Cancer Center | View | |
| P30CA093373 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2014-02668 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |