Phase 1 Trial of Oral Ixabepilone

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21 days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and safety of this dosing schedule in participants with advanced cancer

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

Details

• Lead Sponsor: R-Pharm
• Treatments: Epothilones

Criteria

Inclusion Criteria:

• Males and females, 18 or older

• Histologically or cytologically confirmed diagnosis of solid tumor malignancy

• Measurable or non-measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria

• Karnofsky Performance Status (KPS) of 70-100

• Recovered from toxicities resulting from previous therapies

Exclusion Criteria:

• More than 3 prior cytotoxic regimens in the metastatic setting

• Current or recent gastrointestinal (GI) disease that would impact the absorption of study drug

• Inability to swallow whole capsules

• Inadequate hepatic and renal function

• Function exposure to any epothilone