An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.
Inclusion Criteria:
- ECOG status of 0-2.
Exclusion Criteria:
- Unable to swallow pills.
- Current or recent GI disease or GI surgery.
- Brain mets.
- Severe nerve damage.
- ANC <1,500/mm3
- Platelets <125K.
- Bilirubin >=1.5 times the IULN.
- ALT/AST >=1.5 times the IULN.
- Creatine >1.5 times the IULN.
- Prior treatment with Ixabepilone.
- Strong use of CYPP450 drugs.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination.
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA163-088
NCT ID:
NCT00309049
Start Date:
April 2006
Completion Date:
May 2007
Related Keywords:
- Cancer
Name | Location |
|---|---|
| Local Institution | Washington, District of Columbia |
| Local Institution | Detroit, Michigan |
