©2025 Stanford Medicine
Phase 1 Trial of Oral Ixabepilone
Not Recruiting
Trial ID: NCT00632424
Purpose
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
Winston Chen and Phyllis Huang Professor
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.
Colleen Haas Chair in the School of Medicine
Eligibility
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
Intervention(s):
drug: Ixabepilone (oral formulation)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061