NCT00326131

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

March 2, 2010

Status Verified

August 1, 2007

Enrollment Period

11 months

First QC Date

May 15, 2006

Last Update Submit

February 27, 2010

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

Interventions

Oral TaxaneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

taxane

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 16, 2006

Study Start

April 1, 2006

Primary Completion

March 1, 2007

Last Updated

March 2, 2010

Record last verified: 2007-08

Locations

US(1)