A Phase I Study of a Single Dose of Radio-labeled BMS-275... | NCT00326131

Studies
A Phase I Study of a Single Dose of Radio-labeled BMS-275183 in Patients With Advanced Cancer

NCT00326131

Sponsor

Bristol-Myers Squibb

Status

Terminated

Last Update Posted

Mar 2, 2010Estimated

Enrollment

Phase

Phase 1

Conditions

Cancer

Interventions

Oral Taxane

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

Aug 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Apr 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Not provided

First Submitted Date

May 15, 2006

First Submission Date that Met QC Criteria

May 15, 2006

First Posted Date

May 16, 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

Feb 27, 2010

Last Update Posted Date

Mar 2, 2010Estimated

Description Module

Brief Summary

The first purpose of this study is to determine how the body absorbs, metabolizes, and eliminates a single dose of BMS-275183 (labeled with radioactive carbon). Secondly, to measure the levels of BMS-275183 in your blood, study the safety of the drug, and to see what effects it has on your cancer.

Detailed Description

Not provided

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

Name	Type	Description	Arm Group Labels	Other Names
Oral Taxane	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the Pharmacokinetics, metabolism, and routes and extent of elimination of a single dose of [14C] BMS-275183 over a 10 day period.

Secondary Outcomes

Measure	Description	Time Frame
To assess the safety of a single dose of [14C] BMS-275183 followed by a therapeutic regimen of BMS-275183 administered twice weekly

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Non-hematological malignancy that has progressed on standard therapy
No more that 3 prior chemotherapies given for advanced cancer
Adequate renal, hepatic and hematologic function

Exclusion Criteria:

Uncontrolled or significant pulmonary or cardiovascular disease
Active Brain metastases
Inability to swallow capsules
Serious uncontrolled medical disorder or active infection

Accepts Healthy Volunteers

Not provided

Sex

All

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