A Phase I Dose-Escalation Study of BMS-641988 in Patients... | NCT00326586

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

NCT00326586

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jan 25, 2011Estimated

Enrollment

54Actual

Phase

Phase 1

Conditions

Prostate Cancer

Interventions

AR Antagonist (BMS-641988)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

May 15, 2006

First Submission Date that Met QC Criteria

May 15, 2006

First Posted Date

May 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2011

Last Update Posted Date

Jan 25, 2011Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: AR Antagonist (BMS-641988)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess safety and tolerability and to identify a dose for Phase II evaluation		during the dose escalation phase

Secondary Outcomes

Measure	Description	Time Frame
To evaluate pharmacokinetics		throughout the study
To describe preliminary evidence of anit-tumor activity		throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins		Baltimore	Maryland	21231	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C543412	BMS 641988

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided