NCT01090167

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

A Phase I, Open-label, Multi-center Study of Clofarabine (JC0707) in Japanese Patients With Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase I, open-label, multi-center study of Clofarabine administered to Japanese patients with Acute Myeloid Leukemia (AML) who are relapsed/refractory or elderly untreated AML for whom standard induction chemotherapy is unlikely to be of benefit. Cohort 1 will receive 20 mg/m2/day of Clofarabine once daily for five consecutive days, Cohort 2 will receive 30 mg/m2/day, and Cohort 3 will receive 40 mg/m2/day. Patients will receive one cycle as a rule. However, if there is evidence of some hematologic response after one cycle of treatment with Clofarabine, patients may receive up to a maximum of three cycles. If patients fail to achieve CR or CRp after two cycles of treatment with Clofarabine, further dosing for such patients should be stopped. Three patients constituting a cohort will receive Clofarabine and will then be assessed for dose limiting toxicities (DLT) at Cycle 1. If none of these three patients develops DLT, the next cohort will be introduced. If one of them develops DLT, three new patients will be added to the cohort, so that six patients in total are included in the tolerability assessment. In this case, treatment of the next cohort is allowed only in the case the number of patients who develop DLT is still one in this six-patient cohort. If two of the six patients develop DLT, however, the tolerability is ruled out. However, if two DLTs are observed at the 20mg/m2/day dose cohort, new patients will be enrolled at cohort -1 15mg/m2/day; and if no more than one of six patients in the cohort develop DLT, it will be considered as the last cohort for this study.

Conditions

• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	clofarabine	Intravenous, 20 mg/m2, 30 mg/m2, 40 mg/m2

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-03-19
• Last updated: 2014-03-19

Locations

6 sites across 1 country: Japan