An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations
Overview
- Phase
- Phase 2
- Intervention
- CEP-701 60mg
- Conditions
- Leukemia, Myeloid
- Sponsor
- Cephalon
- Enrollment
- 37
- Primary Endpoint
- Blood Samples and/or bone marrow assessments for complete remission (CR), complete tumor clearance (CTC), or hematologic response (HR) from bone marrow
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cycle 1
60mg
Intervention: CEP-701 60mg
Cycle 2
80mg dependent upon response to Cycle 1
Intervention: Cep-701 80mg
Cycle 2b
40mg dependent upon response to Cycle 1
Intervention: Cep-701 40mg
Outcomes
Primary Outcomes
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 Outcomes
- Number of days to response(56 Days)
- Number of days to disease progression(56 Days)
- Levels of FLT-3 phosphorylation inhibition in vivo(56 Days)