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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Tracking Information
First Submitted Date  ICMJE February 7, 2002
First Posted Date  ICMJE February 8, 2002
Last Update Posted Date August 23, 2012
Study Start Date  ICMJE January 2002
Actual Primary Completion Date February 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2012)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00030186 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2012)
  • Number of days to response [ Time Frame: 56 Days ]
    Response as defined by CR, CTC, or HR.
  • Number of days to disease progression [ Time Frame: 56 Days ]
    Response as defined by CR, CTC, or HR.
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation
Official Title  ICMJE An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Myeloid
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cycle 1
    60mg
    Intervention: Drug: CEP-701 60mg
  • Experimental: Cycle 2
    80mg dependent upon response to Cycle 1
    Intervention: Drug: Cep-701 80mg
  • Experimental: Cycle 2b
    40mg dependent upon response to Cycle 1
    Intervention: Drug: Cep-701 40mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
37
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2003
Actual Primary Completion Date February 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00030186
Other Study ID Numbers  ICMJE C0701a/202/ON/US
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Cephalon )
Study Sponsor  ICMJE Cephalon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Teva Pharmaceutical Industries
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP