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

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ClinicalTrials.gov Identifier: NCT00030186
Recruitment Status : Completed
First Posted : February 8, 2002
Last Update Posted : August 23, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Brief 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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid Drug: CEP-701 60mg Drug: Cep-701 80mg Drug: Cep-701 40mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations
Study Start Date : January 2002
Actual Primary Completion Date : February 2003
Actual Study Completion Date : February 2003


Arm Intervention/treatment
Experimental: Cycle 1
60mg
Drug: CEP-701 60mg
60mg orally 2 times a day for 28 days

Experimental: Cycle 2
80mg dependent upon response to Cycle 1
Drug: Cep-701 80mg
80mg 2 times a day, dependent upon response to cycle 1

Experimental: Cycle 2b
40mg dependent upon response to Cycle 1
Drug: Cep-701 40mg
40mg 2 times a day, dependent upon response to cycle 1




Primary Outcome Measures :
  1. Blood Samples and/or bone marrow assessments for complete remission (CR), complete tumor clearance (CTC), or hematologic response (HR) from bone marrow [ Time Frame: 56 days ]
    Response rate of patients with refactory, relapsed, or poor risk acute myeloid leukemia (AML) expressing Fms-like tyrosine kinase 3 (FLT-3) activating mutations. CR is defined as presence of less than 5% myeloblasts in bone marrow with normalized peripheral blood cell counts. HR is defined as a 50% or more decrease in the absolute number of peripheral blast count or at least a 50% reduction in bone marrow blasts.


Secondary Outcome Measures :
  1. Number of days to response [ Time Frame: 56 Days ]
    Response as defined by CR, CTC, or HR.

  2. Number of days to disease progression [ Time Frame: 56 Days ]
    Response as defined by CR, CTC, or HR.

  3. Levels of FLT-3 phosphorylation inhibition in vivo [ Time Frame: 56 Days ]
    The degree of inhibition of FLT-3 autophosphorylation measured in ex vivo bioassay plasma samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Cephalon
ClinicalTrials.gov Identifier: NCT00030186     History of Changes
Other Study ID Numbers: C0701a/202/ON/US
First Posted: February 8, 2002    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by Teva Pharmaceutical Industries ( Cephalon ):
AML
FLT-3 mutation

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms