drugset / Trial / NCT01090167

A Study of Clofarabine in Japanese Patients With Acute Myeloid Leukemia (AML)

NCT01090167

Phase 1 Completed 14 enrolled Genzyme, a Sanofi Company
NaSingle-groupOpen-labelTreatment

Summary

This study is sponsored by Genzyme Japan K.K. The purpose of this study is to assess the safety, tolerability and pharmacokinetics of Clofarabine (JC0707) intravenously administered to Japanese adult patients with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) at 20, 30, and 40 mg/m2/day on a 5-day dose schedule.

Timeline

Start
2010-02
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified 15 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 20 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 30 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 40 mg/m2 Intravenous