NCT00644488

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 25, 2011

Status Verified

May 1, 2009

Enrollment Period

8 months

First QC Date

March 20, 2008

Last Update Submit

January 24, 2011

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

    throughout the study

Secondary Outcomes (4)

  • 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

Study Arms (1)

A1

EXPERIMENTAL

Active

Drug: BMS-641988 (AR#2)

Interventions

BMS-641988 (AR#2)DRUG

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

A1

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Local Institution

Hidaka, Saitama, 3501298, Japan

Location

Local Institution

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Local Institution

Koto-Ku, Tokyo, 1358550, Japan

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

BMS 641988

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 25, 2011

Record last verified: 2009-05

Locations

JP(3)