Phase 1 Trial of Oral Ixabepilone

Not Recruiting

Trial ID: NCT00632424


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

Official Title

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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


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


drug: Ixabepilone (oral formulation)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

New Trial Alerts