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drugset / Trial / NCT00422097

A Phase I Study of Oral Ixabepilone in Subjects With Advanced Cancer

NCT00422097 ↗

Phase 1 Completed 40 enrolled R-Pharm
Non-randomizedCrossoverOpen-labelTreatment

Summary

This study will determine the maximum tolerated dose of oral ixabepilone administered for 5 successive days every 21 days in participants with advanced cancer. The safety, tolerability, and pharmacokinetics of ixabepilone in the body will be studied. In addition, this study will assess preliminary evidence of the effect of food and famotidine on the pharmacokinetics of oral ixabepilone.

Timeline

Start
2007-01
Primary completion
2009-08
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Famotidine Other / unclassified 40 mg Oral
Subject Ixabepilone Small molecule 5 mg Oral
Subject Ixabepilone Small molecule 10 mg Oral
Subject Ixabepilone Small molecule 15 mg Oral
Subject Ixabepilone Small molecule 20 mg Oral
Subject Ixabepilone Small molecule 25 mg Oral
Subject Ixabepilone Small molecule 30 mg Oral

Indications

cancer