©2022 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
Professor of Medicine (Oncology)
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