Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation

Leukemia, Myeloid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030186
• Other study ID #: C0701a/202/ON/US
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2002
• Last updated: August 14, 2012
• Start date: January 2002
• Est. completion date: February 2003

Study information

• Verified date: August 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• CEP-701 60mg
60mg orally 2 times a day for 28 days
• Cep-701 80mg
80mg 2 times a day, dependent upon response to cycle 1
• Cep-701 40mg
40mg 2 times a day, dependent upon response to cycle 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of days to response	Response as defined by CR, CTC, or HR.	56 Days	No
Secondary	Number of days to disease progression	Response as defined by CR, CTC, or HR.	56 Days	No
Secondary	Levels of FLT-3 phosphorylation inhibition in vivo	The degree of inhibition of FLT-3 autophosphorylation measured in ex vivo bioassay plasma samples	56 Days	No