Study of Tipifarnib as Postconsolidation Therapy for Acute Myeloid Leukemia in Patients 60 Years and Older

Study of Tipifarnib as Postconsolidation Therapy for Acute Myeloid Leukemia in Patients 60 Years and Older

An Open-label, Phase 2 Study of the Farnesyl Transferase Inhibitor ZARNESTRA (R115777) as Post-consolidation Therapy for Acute Myeloid Leukemia (AML) in Patients Age 60 Years and Older.

The purpose of this study is to determine if giving tipifarnib after standard treatment will prevent leukemia from coming back (relapsing). Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.

The study is an open-label evaluation of treatment with tipifarnib in approximately 127 subjects, 60 years and older, with AML in complete remission (CR) after consolidation therapy. Prior to enrollment, patients will receive 1 or 2 cycles of induction chemotherapy. Patients who attain a CR will receive 1 or 2 cycles of consolidation chemotherapy. Patients in postconsolidation complete remission who meet the eligibility criteria are offered enrollment in the study. Subjects enrolled in the study are treated with tipifarnib A dose-modification scheme is followed to maintain adequate specified laboratory values and to minimize other adverse events. Postconsolidation treatment with tipifarnib continues until the time of relapse, death, completion of 24 cycles of treatment, or discontinuation as advised by study doctor. Tipifarnib, film coated, compressed tablets containing 100 mg active drug, will be administered orally at a dose of 300 mg (three 100 mg film coated tablets) taken twice a day for 21 consecutive days on a 28-day cycle schedule for up to 24 months.

The primary objective is to determine relapse-free survival (RFS) at 1 year in patients, 60 years and older with AML, who receive tipifarnib treatment.

Secondary objectives, assess: overall survival; time to relapse; the safety profile of treatment with tipifarnib; the population pharmacokinetics of tipifarnib; DNA analysis of genetic variability; RNA analysis of differential gene expression.

Inclusion Criteria: Newly-diagnosed AML Leukemia in remission Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: Acute Promyelocytic Leukemia (APL) Previous History of myelodysplasia or antecedent hematologic malignancy Previous therapy with a farnesyl transferase inhibitor