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

NCT ID: NCT00644488

Last Updated: 2011-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A1

Active

Group Type EXPERIMENTAL

BMS-641988 (AR#2)

Intervention Type DRUG

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

Interventions

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BMS-641988 (AR#2)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Hidaka, Saitama, Japan

Site Status

Local Institution

Hamamatsu, Shizuoka, Japan

Site Status

Local Institution

Koto-Ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CA185-005

Identifier Type: -

Identifier Source: org_study_id

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