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

NCT00030186 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2012-08-23

No results posted yet for this study

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.

Conditions

  • Leukemia, Myeloid

Interventions

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

Sponsors & Collaborators

  • Cephalon

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2003-02-28
Completion
2003-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00030186 on ClinicalTrials.gov