Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
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 [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 [56 Days]
Response as defined by CR, CTC, or HR.
- Number of days to disease progression [56 Days]
Response as defined by CR, CTC, or HR.
- Levels of FLT-3 phosphorylation inhibition in vivo [56 Days]
The degree of inhibition of FLT-3 autophosphorylation measured in ex vivo bioassay plasma samples
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Cephalon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C0701a/202/ON/US