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Completed

NCT Number: NCT00644488

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Hidaka, Saitama, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-641988 (AR#2)

Drug

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

Primary outcomes

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

    Time frame: throughout the study

Secondary outcomes

  1. To evaluate the pharmacokinetics of BMS-641988 and the metabolites BMS-501949 and BMS-570511

    Time frame: at cycle 1 day 1, day 15 and day 29

  2. To identify the dose(s) of BMS-641988 for Phase II

    Time frame: at the end of study

  3. To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans

    Time frame: throughout the study

  4. To assess the effects of BMS-641988 on pharmacodynamic markers (LH, total and free testosterone, 5(alpha)-DHT, estradiol, prolactin, FSH, and SHBG)

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 26, 2008
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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