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
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics: Core binding factor acute myeloid leukemia Cytogenetically normal acute myeloid leukemia Familial acute myeloid leukemia with mutated CEBPA
Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia
Experimental: Cycle 1
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 :
- 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 :
- 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
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