A Study of the Alternative Administration of Ixabepilone and Vinflunine

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: vinflunine + ixabepilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362830

CA183-008

Details and patient eligibility

About

The purpose of the study is to test how vinflunine interacts with ixabepilone in the human body.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ECOG status of 0-1

Exclusion criteria

• Inability to tolerate venous access
• Brain mets
• Severe nerve damage
• ANC <2,000/mm3
• Platelets <100K
• Bilirubin >= 1.5 times the IULN
• ALT/AST >= 2.5 times the IULN
• Creatinine <50 mL/min
• Prior treatment with vinflunine and/or ixabepilone
• Strong use of CYPP450 drugs

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 1 patient group

1

Experimental group

Treatment:

Drug: vinflunine + ixabepilone