NCT00326586

Brief Summary

This is a Phase I Dose-Escalation Study of BMS641988 in 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
54

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started May 2006

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

Study Start

First participant enrolled

May 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
2.8 years 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

July 1, 2009

Enrollment Period

2.8 years

First QC Date

May 15, 2006

Last Update Submit

January 24, 2011

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

    during the dose escalation phase

Secondary Outcomes (2)

  • To evaluate pharmacokinetics

    throughout the study

  • To describe preliminary evidence of anit-tumor activity

    throughout the study

Study Arms (1)

1

EXPERIMENTAL
Drug: AR Antagonist (BMS-641988)

Interventions

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

1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

University Of Wisconsin Hospital And Clinics Laboratory

Madison, Wisconsin, 53792, United States

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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

May 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 25, 2011

Record last verified: 2009-07

Locations

US(3)