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


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

during the dose escalation phase

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA185-002

NCT ID:

NCT00326586

Start Date:

May 2006

Completion Date:

March 2009

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
University Of Wisconsin Hospital And Clinics LaboratoryMadison, Wisconsin  53792