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Home > "O" Clinical Trials Conditions > Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation  Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation
Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation
For Condition: Leukemia, Myeloid
Status: No longer recruiting
Sponsor(s): Cephalon ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 37
Location and Contact Information:
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 70030
United States
Johns Hopkins Oncology Center, Bunting Blaustein Building
Baltimore, Maryland, 21231
United States
Additional Information:
Study ID Numbers: C0701a/202/ON/US;
Study Start Date: January 2002
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030186
Other Leukemia, Myeloid Studies:
1. Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation
2. Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients
3. Clofarabine plus cytarabine in patients with previously untreated acute myeloid leukemia and high-risk myelodysplastic syndrome
4. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
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Open Study of CEP-701 in Patients with Refractory Acute Myeloid Leukemia with FLT-3 Mutation
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