A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00644488

Enrollment

Registered

2008-03-26

Start date

2008-07-31

Completion date

2009-03-31

Last updated

2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

The purpose of this clinical study is to assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer

Interventions

DRUGBMS-641988 (AR#2)

Tablets, Oral, 20 mg, 40 mg, 60 mg, 100 mg, once daily, 24 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
To assess the effects of BMS-641988 on pharmacodynamic markers (LH, total and free testosterone, 5(alpha)-DHT, estradiol, prolactin, FSH, and SHBG)	throughout the study

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026