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Effect of Capecitabine on the Pharmacokinetics of BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Neoplasms

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Trial Information

Effect of Capecitabine on the Pharmacokinetics of BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies


Inclusion Criteria:



- Recovery from surgery or radiation therapy

- Measurable or non-measurable disease

- Available for follow-up

Exclusion Criteria:

- Neuropathy

- Uncontrolled pulmonary or cardiovascular disease

- Known history of HIV infection

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effect of capecitabine on the pharmacokinetics of BMS-247550 and to assess the effect of BMS-247550 on the pharmacokinetics of capecitabine

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA163-038

NCT ID:

NCT00207129

Start Date:

October 2004

Completion Date:

December 2005

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms
  • Neoplasms

Name

Location

Local InstitutionAustin, Texas