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

This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant Prostate Cancer.

Completed

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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

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Advanced castration-resistant prostate carcinoma with progressive disease
At least 4 weeks must have elapsed from major surgery
Patient must be available for follow-up
Adequate liver and kidney function
Adequate blood values

Exclusion criteria

Uncontrolled or significant heart disease
History of seizures
History of head injury, loss of consciousness, or stroke
Patients undergoing alcohol withdrawal
Any concurrent cancer
A serious uncontrolled medical disorder or active infection
Inability to swallow tablets

Treatment and study plan

AR Antagonist (BMS-641988)

Drug

Tablets, Oral, 6 Patients will be randomized in a 1:1 ratio and in a double-blinded fashion to achieve a single dose of the study drug or Placebo on C1D1. Once daily, at least 3 cycles until the disease progresses

Primary outcomes

To assess safety and tolerability and to identify a dose for Phase II evaluation

Time frame: during the dose escalation phase

Secondary outcomes

To evaluate pharmacokinetics

Time frame: throughout the study
To describe preliminary evidence of anit-tumor activity

Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: May 17, 2006
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.

Published trials that share one or more normalized conditions with this study.

Completed