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

NCT ID: NCT00030186

Last Updated: 2012-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2003-02-28

Brief Summary

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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

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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

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Leukemia, Myeloid

Keywords

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AML FLT-3 mutation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cycle 1

60mg

Group Type EXPERIMENTAL

CEP-701 60mg

Intervention Type DRUG

60mg orally 2 times a day for 28 days

Cycle 2

80mg dependent upon response to Cycle 1

Group Type EXPERIMENTAL

Cep-701 80mg

Intervention Type DRUG

80mg 2 times a day, dependent upon response to cycle 1

Cycle 2b

40mg dependent upon response to Cycle 1

Group Type EXPERIMENTAL

Cep-701 40mg

Intervention Type DRUG

40mg 2 times a day, dependent upon response to cycle 1

Interventions

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CEP-701 60mg

60mg orally 2 times a day for 28 days

Intervention Type DRUG

Cep-701 80mg

80mg 2 times a day, dependent upon response to cycle 1

Intervention Type DRUG

Cep-701 40mg

40mg 2 times a day, dependent upon response to cycle 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patient must have confirmed diagnosis of refractory or relapsed AML that expresses a FLT-3 mutation
* patient must have life expectancy of more than 2 months
* patient must be fully recovered from reversible side effects of previous therapy for cancer

Exclusion Criteria

* total bilirubin, ALT or AST greater than 2 times upper limit of normal
* patient \<65 years of age with estimated creatinine clearance less than 60 mL/min; patient \>65 years of age with serum creatinine \> 1.5 times the upper limit of normal (ULN)
* received any investigational drug within past 4 weeks
* GI disturbance/malabsorption that may affect absorption of CEP-701
* HIV positive
* received NSAID within prior 14 days
* has active infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cephalon

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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C0701a/202/ON/US

Identifier Type: -

Identifier Source: org_study_id