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AR Antagonist

Phase 1

Prostate Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 25, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

AR Antagonist · 1 trial · 1 indication

Phase 1 1
NCT00326586A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate CancerProstate Cancer
COMPLETED54 Analytics
PHASE1COMPLETED
A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess safety and tolerability and to identify a dose for Phase II evaluation
during the dose escalation phase

Secondary Endpoints

To evaluate pharmacokinetics
throughout the study
To describe preliminary evidence of anit-tumor activity
throughout the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
AR Antagonist (BMS-641988)DRUGTablets, Oral, 6 Patients will be randomized in a 1:1 ratio and in a double-blinded fashion to achieve a single dose of the study drug or Placebo on C1D1. Once daily, at least 3 cycles until the disease progresses
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Advanced castration-resistant prostate carcinoma with progressive disease * At least 4 weeks must have elapsed from major surgery * Patient must be available for follow-up * Adequate liver and kidney function * Adequate blood values Exclusion Criteria: * Uncontrolled or sign...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about AR Antagonist

What is AR Antagonist used for in prostate cancer?

AR Antagonist is an investigational small molecule being studied for the treatment of castration-resistant prostate cancer. It is designed to target the androgen receptor pathway, which plays a role in prostate cancer progression. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does AR Antagonist target?

AR Antagonist targets the androgen receptor, a protein involved in the growth and progression of prostate cancer. By blocking this receptor, the drug aims to inhibit cancer cell proliferation. This mechanism is being evaluated in patients with castration-resistant prostate cancer, a form of the disease that no longer responds to standard hormone therapy.

Who makes AR Antagonist?

AR Antagonist is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with prostate cancer.

What phase is AR Antagonist in?

AR Antagonist is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The Phase 1 trial is designed to assess the drug's safety, tolerability, and dosing in patients with castration-resistant prostate cancer.

What clinical trials is AR Antagonist in?

AR Antagonist has been studied in one clinical trial, identified as NCT00326586. This was a Phase 1 dose-escalation study of BMS-641988 in patients with castration-resistant prostate cancer. The trial, which enrolled 54 participants in the United States, has been completed. The study was randomized, double-blind, and uncontrolled.

Is AR Antagonist the same as BMS-641988?

Yes, AR Antagonist is also known as BMS-641988. The Phase 1 clinical trial NCT00326586, titled 'A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer,' used this alternative name. Both names refer to the same investigational small molecule being developed by Bristol-Myers Squibb.