drugset / Trial / NCT01418677

An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function

NCT01418677

Phase 1 Completed 19 enrolled Eisai Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.

Timeline

Start
2011-10
Primary completion
2014-07
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Eribulin Small molecule 0.7 mg/m2 Intravenous
Comparator Eribulin Small molecule 1.1 mg/m2 Intravenous
Comparator Eribulin Small molecule 1.4 mg/m2 Intravenous