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BMS-641988

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

UNCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

BMS-641988 · 1 trial · 1 indication

Phase 1 1
NCT00644488A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate CancerProstate Cancer
COMPLETED7 Analytics
PHASE1COMPLETED
A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer
throughout the study

Secondary Endpoints

To evaluate the pharmacokinetics of BMS-641988 and the metabolites BMS-501949 and BMS-570511
at cycle 1 day 1, day 15 and day 29
To identify the dose(s) of BMS-641988 for Phase II
at the end of study
To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans
throughout the study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A1EXPERIMENTALActive

Interventions

NameTypeDescription
BMS-641988 (AR#2)DRUGTablets, Oral, 20 mg, 40 mg, 60 mg, 100 mg, once daily, 24 weeks
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Eligibility Criteria

Age Range20 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients with castration-resistant prostate cancer and serum testosterone ≤50 ng/dL progressive to current therapy who satisfy the inclusion and exclusion criteria

Countries:Japan
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about BMS-641988

What is BMS-641988 used for in prostate cancer?

BMS-641988 is an investigational small molecule being studied for the treatment of castration resistant prostate cancer. It is being developed by Bristol-Myers Squibb Company. As of the available data, it is in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes BMS-641988?

BMS-641988 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The drug is an investigational small molecule in Phase 1 clinical development for prostate cancer.

What phase is BMS-641988 in?

BMS-641988 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 study of the drug in Japanese patients with castration resistant prostate cancer has been completed.

What clinical trials is BMS-641988 in?

BMS-641988 has one completed clinical trial, identified as NCT00644488. This was a Phase 1 study in Japanese patients with castration resistant prostate cancer, enrolling 7 male participants aged 20 years and older. The trial was uncontrolled and not randomized or blinded.

Is BMS-641988 FDA approved?

BMS-641988 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for prostate cancer. The available data shows one completed Phase 1 trial, but no approval status has been established.