A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer
Inclusion Criteria:
- ECOG status of 0-1
Exclusion Criteria:
- Inability to tolerate venous access
- Brain mets
- Severe nerve damage
- ANC <2,000/mm3
- Platelets <100K
- Bilirubin >= 1.5 times the IULN
- ALT/AST >= 2.5 times the IULN
- Creatinine <50 mL/min
- Prior treatment with vinflunine and/or ixabepilone
- Strong use of CYPP450 drugs
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen.
Outcome Time Frame:
upon occurrence
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA183-008
NCT ID:
NCT00362830
Start Date:
August 2006
Completion Date:
September 2007
Related Keywords:
- Cancer
Name | Location |
|---|---|
| The Cleveland Clinic Foundation | Cleveland, Ohio |
| University Of Miami Miller School Of Medicine | Miami, Florida 33010 |
