Ixabepilone Administered as an Enteric Coated Formulation.

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: Ixabepilone

• Registration Number: NCT00309049
• Lead Sponsor: R-Pharm

Brief Summary

The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-29
• Study First Submitted QC: 2006-03-30
• Study First Posted: 2006-03-31
• Study Start: 2006-04
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A2	Ixabepilone	-
A3	Ixabepilone	-
A1	Ixabepilone	-

Primary Outcome Measures

Name	Time	Method
Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination.

Secondary Outcome Measures

Name	Time	Method
Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body.

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Detroit, Michigan, United States