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

Primary Purpose

Leukemia, Myeloid

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CEP-701 60mg
Cep-701 80mg
Cep-701 40mg
Sponsored by
Cephalon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid focused on measuring AML, FLT-3 mutation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Cycle 1

    Cycle 2

    Cycle 2b

    Arm Description

    60mg

    80mg dependent upon response to Cycle 1

    40mg dependent upon response to Cycle 1

    Outcomes

    Primary Outcome Measures

    Blood Samples and/or bone marrow assessments for complete remission (CR), complete tumor clearance (CTC), or hematologic response (HR) from bone marrow
    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

    Number of days to response
    Response as defined by CR, CTC, or HR.
    Number of days to disease progression
    Response as defined by CR, CTC, or HR.
    Levels of FLT-3 phosphorylation inhibition in vivo
    The degree of inhibition of FLT-3 autophosphorylation measured in ex vivo bioassay plasma samples

    Full Information

    First Posted
    February 7, 2002
    Last Updated
    August 14, 2012
    Sponsor
    Cephalon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00030186
    Brief Title
    Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    February 2003 (Actual)
    Study Completion Date
    February 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cephalon

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia, Myeloid
    Keywords
    AML, FLT-3 mutation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cycle 1
    Arm Type
    Experimental
    Arm Description
    60mg
    Arm Title
    Cycle 2
    Arm Type
    Experimental
    Arm Description
    80mg dependent upon response to Cycle 1
    Arm Title
    Cycle 2b
    Arm Type
    Experimental
    Arm Description
    40mg dependent upon response to Cycle 1
    Intervention Type
    Drug
    Intervention Name(s)
    CEP-701 60mg
    Intervention Description
    60mg orally 2 times a day for 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Cep-701 80mg
    Intervention Description
    80mg 2 times a day, dependent upon response to cycle 1
    Intervention Type
    Drug
    Intervention Name(s)
    Cep-701 40mg
    Intervention Description
    40mg 2 times a day, dependent upon response to cycle 1
    Primary Outcome Measure Information:
    Title
    Blood Samples and/or bone marrow assessments for complete remission (CR), complete tumor clearance (CTC), or hematologic response (HR) from bone marrow
    Description
    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.
    Time Frame
    56 days
    Secondary Outcome Measure Information:
    Title
    Number of days to response
    Description
    Response as defined by CR, CTC, or HR.
    Time Frame
    56 Days
    Title
    Number of days to disease progression
    Description
    Response as defined by CR, CTC, or HR.
    Time Frame
    56 Days
    Title
    Levels of FLT-3 phosphorylation inhibition in vivo
    Description
    The degree of inhibition of FLT-3 autophosphorylation measured in ex vivo bioassay plasma samples
    Time Frame
    56 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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