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

Pharmacokinetics and Metabolism of [14C] BMS-275183 in Patients With Advanced Cancer

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00326131

Enrollment

Registered

2006-05-16

Start date

2006-04-30

Completion date

Unknown

Last updated

2010-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

DRUGOral Taxane

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026