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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Cancer

Treatments: Drug: Oral Taxane

Study type: Interventional

Funder types: Industry

Identifiers

NCT00326131

CA165-017

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)