Cancer
Conditions
Brief summary
The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.
Interventions
DRUGIxabepilone
Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of IV oral and oral dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.
Sponsors
R-Pharm
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body. | — |
Countries
United States
Outcome results
None listed