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Antiandrogen

Venetoclax for 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 from the time measurement criteria are met for cr or pr (whichever status is recorded first) until the first date that radiographic progression is documented per pcwg3, assessed up to 3 years

Awards & highlights

Study Summary

This trial tests the side effects and best dose of venetoclax when given with enzalutamide to treat patients with castration resistant prostate cancer.

Eligible Conditions

Castration-resistant Prostate Cancer
Prostate Cancer
Low Testosterone
Prostate-Specific Antigen

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time measurement criteria are met for cr or pr (whichever status is recorded first) until the first date that radiographic progression is documented per pcwg3, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time measurement criteria are met for cr or pr (whichever status is recorded first) until the first date that radiographic progression is documented per pcwg3, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time measurement criteria are met for cr or pr (whichever status is recorded first) until the first date that radiographic progression is documented per pcwg3, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD) (Phase Ib)

Progression free survival (Phase II)

Recommended phase 2 dose (RP2D) (Phase Ib)

Secondary outcome measures

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)

Duration of response (DOR) (Phase II)

Overall response rate (ORR) (Phase II)

+7 more

Other outcome measures

Biomarker analysis

Observed serum concentration of enzalutamide

Observed serum concentration of venetoclax

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

~1990

Enzalutamide

2014

Completed Phase 4

~2760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor

962 Previous Clinical Trials

503,103 Total Patients Enrolled

5 Trials studying Prostate Cancer

1,578 Patients Enrolled for Prostate Cancer

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

31,097 Total Patients Enrolled

20 Trials studying Prostate Cancer

636 Patients Enrolled for Prostate Cancer

Gurkamal ChattaPrincipal InvestigatorRoswell Park Cancer Institute

1 Previous Clinical Trials

Media Library

Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03751436 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for individuals to take part in this experiment?

"This research endeavour, which had been posted on August 2nd 2019 and was last updated 15th of August 2022, is no longer accepting applicants. However, there are still 3971 clinical trials actively seeking patients at the present moment."

Answered by AI

How many individuals are being recruited for this clinical research?

"Unfortunately, this research initiative is no longer enrolling patients. The study was initially posted on August 2nd 2019 and had its last update on 8/15/2022. If you are looking for alternative options, there are presently 3656 trials recruiting individuals with malignant neoplasms of prostate and 315 studies admitting participants in Venetoclax treatments."

Answered by AI

What prior experiments have been performed involving Venetoclax?

"Currently, there are 315 investigations into Venetoclax in active development with 58 of them reaching the Phase 3 stage. Toronto is an epicentre for these trials but many other locations across North America also offer studies on this drug."

Answered by AI