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BMS-641988

Phase 1

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

BMS-641988 target and mechanism

ModalitySmall molecule

Also known as BMS-641988 (AR#2)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

BMS-641988 clinical trials

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 417 trials

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Frequently asked questions about BMS-641988

What is BMS-641988?

BMS-641988 is an investigational small molecule developed by Bristol-Myers Squibb for the treatment of prostate cancer. It was studied in a Phase 1 clinical trial in Japanese patients with castration resistant prostate cancer. It is not an approved medicine and remains an experimental agent in clinical development.

What is BMS-641988 used for in prostate cancer?

BMS-641988 was studied for castration resistant prostate cancer, an advanced form of prostate cancer that continues to progress despite androgen deprivation therapy. The single Phase 1 trial enrolled Japanese men with this condition. No approved use has been established for BMS-641988.

Who makes BMS-641988?

Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, developed BMS-641988. The company sponsored the Phase 1 study of the compound in Japanese patients with castration resistant prostate cancer.

What phase is BMS-641988 in?

BMS-641988 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The study was an uncontrolled, open-label dose evaluation rather than a randomized or double-blind design, and it enrolled seven patients.

What clinical trials is BMS-641988 in?

BMS-641988 was evaluated in one completed Phase 1 trial, NCT00644488, titled A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer. The trial enrolled seven men aged 20 years and older in Japan and is listed as completed.

Is BMS-641988 the same as BMS-641988 (AR#2)?

Yes. BMS-641988 is also referred to as BMS-641988 (AR#2). Both names refer to the same investigational Bristol-Myers Squibb compound studied in castration resistant prostate cancer, so searches under either name point to the same drug asset.