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Clinical Trial Summary

The primary objective of this study was to assess the effect of cytochrome P450 3A4 enzyme (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin mesylate following intravenous (IV) administration in participants with advanced solid tumors. The secondary objectives of this study were to assess the safety of eribulin mesylate when co-administered with rifampicin and assess the safety and activity of eribulin mesylate as a single agent.


Clinical Trial Description

The study consisted of 3 phases: Pre-Treatment, Treatment, and Extension. Pre-Treatment Phase had 2 periods: Screening and Baseline. Treatment Phase consisted of intensive PK assessment with eribulin mesylate given IV alone on Day 1 followed by eribulin mesylate given IV on Day 15 with rifampicin given orally from Days 9 to 20. Extension Phase allowed eribulin mesylate treatment to continue for participants without progressive disease or unacceptable toxicity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03002493
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 1
Start date December 2009
Completion date June 2011

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