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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326586
• Other study ID #: CA185-002
• Status: Completed
• Phase: Phase 1
• First received: May 15, 2006
• Last updated: January 24, 2011
• Start date: May 2006
• Est. completion date: March 2009

Study information

• Verified date: July 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• AR Antagonist (BMS-641988)
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

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins	Baltimore	Maryland
United States	University Of Wisconsin Hospital And Clinics Laboratory	Madison	Wisconsin
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess safety and tolerability and to identify a dose for Phase II evaluation		during the dose escalation phase	Yes
Secondary	To evaluate pharmacokinetics		throughout the study	No
Secondary	To describe preliminary evidence of anit-tumor activity		throughout the study	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form