Phase 1 Trial of Oral Ixabepilone

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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

Key facts

Study ID

NCT00632424

Run by

R-Pharm

People needed

23

Starts

2008-05-01

Expected to finish

2009-06-01

Last updated by the study team

2016-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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