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

R-Pharm

Status and phase: Completed; Phase 1

Conditions: Neoplasms; Advanced Solid Tumors

Treatments: Drug: Capecitabine; Drug: Ixabepilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00207129

CA163-038

Details and patient eligibility

About

The purpose of this study is to test how BMS-247550 (ixabepilone) affects the removal of capecitabine from the body and how capecitabine affects the removal of BMS-247550 from the body.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Ixabepilone

B

Experimental group

Treatment:

Drug: Capecitabine