NCT00309049CompletedPhase 1
An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.
R-Pharm1 site in 1 country30 target enrollmentStarted: April 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination.
Study Overview
Brief Summary
The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A1
Active Comparator
Intervention: Ixabepilone (Drug)
A2
Active Comparator
Intervention: Ixabepilone (Drug)
A3
Active Comparator
Intervention: Ixabepilone (Drug)
Outcomes
Primary Outcomes
Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination.
Secondary Outcomes
- Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body.
Investigators
Study Sites (1)
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