Status:
COMPLETED
A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer
Lead Sponsor:
R-Pharm
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will determine the maximum tolerated dose of oral ixabepilone administered for 5 successive days every 21 days in participants with advanced cancer. The safety, tolerability, and pharmacoki...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of solid tumor malignancy unresponsive to current treatment options
- Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors
- Lapse of at least 1 week since minor surgery and of at least 3 weeks since major surgery and radiation therapy
- Eastern Cooperative Oncology Group performance status of 0-1
- Lapse of at least 4 weeks since immunotherapy or chemotherapy
- Negative pregnancy test result within 72 hours of study drug administration for any woman of childbearing potential (WOCBP)
Exclusion
- WOCBP unable or unwilling to use birth control during study and for up to 4 weeks after study completion
- Women who are pregnant or breastfeeding
- Fertile men not using effective birth control with partners who are WOCBP
- Gastrointestinal(GI) disease or GI tract surgery that could impact drug absorption
- Inability to swallow capsules
- Inability to be venipunctured or to tolerate venous access
- Known symptomatic brain metastases
- Common Terminology Criteria for Adverse Events Grade 2 or greater neuropathy or history of Grade 3 or greater neuropathy
- Psychiatric conditions inhibiting compliance with protocol requirements
- Uncontrolled medical disorder or active infection that would impair participant's ability to receive protocol therapy or whose control may be jeopardized by the study treatment protocol
- Inadequate hematologic, hepatic, or renal function
- History of significant drug allergy
- Previous exposure to ixabepilone
- Exposure to any investigational drug or placebo within 4 weeks of enrollment
- Concurrent chemotherapy regimen
- Use of cytochrome P4503A4 inhibitors or inducers within 2 weeks of treatment initiation (unless approved by medical monitor)
- Use of steroids (except as antiemetic)
- Prisoners or subjects involuntarily detained for treatment
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00422097
Start Date
January 1 2007
End Date
April 1 2011
Last Update
March 10 2016
Active Locations (2)
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1
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007
2
Wayne State University (Hwcrc)
Detroit, Michigan, United States, 48201