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Hormone Therapy

BMS-986460 for Prostate Cancer

Phase 1

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate.

Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 212 weeks

Awards & highlights

Study Summary

This trial tests a new drug to treat advanced prostate cancer in men to see if it's safe and effective.

Who is the study for?

This trial is for men with advanced prostate cancer that has spread and doesn't respond to hormone therapy. They should be relatively healthy, able to perform daily activities (ECOG 0-1), and have a PSA level of at least 2 ng/mL. Men can't join if they have serious health issues, brain metastases, or significant heart disease.Check my eligibility

What is being tested?

The study is testing BMS-986460's safety and early effectiveness in treating metastatic castration-resistant prostate cancer. Participants will receive this investigational drug to see how well it works and what side effects it may cause.See study design

What are the potential side effects?

While the specific side effects of BMS-986460 are not listed here, common ones for cancer treatments include fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, liver function changes, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has been confirmed by a lab test.

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My prostate cancer has worsened despite hormone therapy and at least one other treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 212 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 212 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 212 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of deaths

Number of participants with AEs leading to study intervention discontinuation

Number of participants with AEs meeting protocol defined dose limiting toxicity (DLT) criteria

+2 more

Secondary outcome measures

Area under the plasma concentration-time curve (AUC)

Duration of response (DOR)

Maximum concentration (Cmax)

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of BMS-986460Experimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,129,974 Total Patients Enrolled

42 Trials studying Prostate Cancer

5,447 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

Are there currently open enrollments for this research study?

"Clinicialtrials.gov shows that this medical trial, which first appeared on October 23rd 2023 and was recently revised on September 28th 2023, is no longer recruiting participants. However, there are many other trials currently enrolling patients - 1269 in total."

Answered by AI

Has the FDA granted clearance to utilize BMS-986460 for medical purposes?

"Due to the preliminary nature of this medical trial, our team at Power rated Administration of BMS-986460 a 1 on its safety scale. This score is reflective of limited supporting data regarding both efficacy and risk mitigation."

Answered by AI

How many locations has this clinical research been implemented in?

"At the time of writing, 7 different medical centres are taking part in this trial. Florida Cancer Specialists Sarasota Drug Development Unit (Sarasota), Dana-Farber Cancer Institute (Boston), and Memorial Sloan Kettering Cancer Center (New york) to name a few."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer

2023. "A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067841.

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