drugset / Trial / NCT01000376

Evaluating the Pharmacokinetics and Tolerance of Co-administration of Oral Multiple Dose of Ketoconazole and an IV (Bolus) Infusion of Eribulin in Patients With Advanced Solid Tumors

NCT01000376

Phase 1 Completed 12 enrolled Eisai Inc.
Non-randomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to investigate whether ketoconazole, taken orally, influences the level of eribulin in the blood when the two drugs are given at the same time. The study will enroll patients with solid tumors whose cancer became worse even after standard treatment, or for whom there is no standard treatment available. The study will also investigate whether eribulin given together with ketoconazole is safe (has few side-effects) and is effective against cancer.

Timeline

Start
2009-02
Primary completion
2009-08
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Eribulin Small molecule 0.7 mg/m2 Intravenous
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous
Subject Ketoconazole Small molecule 200 mg Oral

Indications