Phase 1 Trial of Oral Ixabepilone

A Phase 1 Study of Ixabepilone Administered as 3 Oral Doses Each Separated by 6 Hours Every 21 Days in Subjects With Advanced Cancer

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

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