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 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration