Ixabepilone Administered as an Enteric Coated Formulation.

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb; R-Pharm
• Treatments: Epothilones

Criteria

Inclusion Criteria:

• ECOG status of 0-2.

Exclusion Criteria:

• Unable to swallow pills.

• Current or recent GI disease or GI surgery.

• Brain mets.

• Severe nerve damage.

• ANC <1,500/mm3

• Platelets <125K.

• Bilirubin >=1.5 times the IULN.

• ALT/AST >=1.5 times the IULN.

• Creatine >1.5 times the IULN.

• Prior treatment with Ixabepilone.

• Strong use of CYPP450 drugs.