drugset / Trial / NCT03002493

To Assess the Effect of Rifampicin on the Pharmacokinetics of Eribulin Mesylate in Participants With Advanced Solid Tumors

NCT03002493

Phase 1 Completed 14 enrolled Eisai Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2009-12
Primary completion
2011-02
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous
Subject Rifampin Small molecule 600 mg Oral

Indications