Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation
An Open-Label Study of CEP-701 in Patients With Refractory, Relapsed, or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations
1 other identifier
interventional
37
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2002
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 7, 2002
CompletedFirst Posted
Study publicly available on registry
February 8, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedAugust 23, 2012
August 1, 2012
1.1 years
February 7, 2002
August 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
56 days
Secondary Outcomes (3)
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
Study Arms (3)
Cycle 1
EXPERIMENTAL60mg
Cycle 2
EXPERIMENTAL80mg dependent upon response to Cycle 1
Cycle 2b
EXPERIMENTAL40mg dependent upon response to Cycle 1
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2002
First Posted
February 8, 2002
Study Start
January 1, 2002
Primary Completion
February 1, 2003
Study Completion
February 1, 2003
Last Updated
August 23, 2012
Record last verified: 2012-08