Status:
TERMINATED
Phase 1 Trial of Oral Ixabepilone
Lead Sponsor:
R-Pharm
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 dosin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00632424
Start Date
May 1 2008
End Date
June 1 2009
Last Update
March 10 2016
Active Locations (2)
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1
Stanford University
Stanford, California, United States, 94305
2
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007