NCT00030186

Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation

An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day.

Detailed description

This is an open-label study of CEP-701 in patients with refractory, relapsed, or poor risk AML expressing FLT-3 activating mutations. Patients who meet eligibility criteria will be enrolled at a dosage of 60 mg orally 2 times a day for 28 days (1 cycle). Upon completion of cycle 1, the dosage may be increased to 80mg 2 times a day or decreased to 40 mg 2 times a day, dependent upon response to 60 mg dosage.

Conditions

• Leukemia, Myeloid

Interventions

Type	Name	Description
DRUG	CEP-701 60mg	60mg orally 2 times a day for 28 days
DRUG	Cep-701 80mg	80mg 2 times a day, dependent upon response to cycle 1
DRUG	Cep-701 40mg	40mg 2 times a day, dependent upon response to cycle 1

Timeline

• Start date: 2002-01-01
• Primary completion: 2003-02-01
• Completion: 2003-02-01
• First posted: 2002-02-08
• Last updated: 2012-08-23