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Antiandrogen

Enzalutamide With Venetoclax in Treating Patients With Metastatic Castration Resistant Prostate Cancer

Phase 1

Waitlist Available

Led By Gurkamal Chatta

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the combination of Venetoclax and Enzalutamide in patients with advanced prostate cancer that doesn't respond to standard treatments. Venetoclax targets resistant cancer cells, and Enzalutamide reduces hormone levels that help the cancer grow. Enzalutamide is a nonsteroidal antiandrogen used to treat advanced prostate cancer and has shown improved survival rates in clinical trials.

Eligible Conditions

Prostate Cancer
Low Testosterone
Prostate-Specific Antigen

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD) (Phase Ib)

Progression free survival (Phase II)

Recommended phase 2 dose (RP2D) (Phase Ib)

Secondary study objectives

Circulating tumor cell (CTC) conversion in patients who enter the trial with unfavorable CTCs (five or more cells per 7.5 mL of blood) (Phase II)

Overall response rate (ORR) (Phase II)

Overall survival (Phase II)

+2 more

Other study objectives

Biomarker analysis

Observed serum concentration of enzalutamide

Observed serum concentration of venetoclax

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (venetoclax, enzalutamide)Experimental Treatment2 Interventions

Patients receive venetoclax PO QD and enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2240

Enzalutamide

2014

Completed Phase 4

~3820