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

Cephalon

Status and phase: Completed; Phase 2

Conditions: Leukemia, Myeloid

Treatments: Drug: Cep-701 80mg; Drug: CEP-701 60mg; Drug: Cep-701 40mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00030186

C0701a/202/ON/US

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

37 participants in 3 patient groups

Cycle 1

Experimental group

Description:

60mg

Treatment:

Drug: CEP-701 60mg

Cycle 2

Experimental group

Description:

80mg dependent upon response to Cycle 1

Treatment:

Drug: Cep-701 80mg

Cycle 2b

Experimental group

Description:

40mg dependent upon response to Cycle 1

Treatment:

Drug: Cep-701 40mg