A Phase II Study of the Farnesyltransferase Inhibitor ZARNESTRA (Tipifarnib, R115777, NSC #702818, IND #58,359) in Complete Remission Following Induction and/or Consolidation Chemotherapy in Adults With Poor-Risk Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplasia (MDS).
I. To determine the duration of disease-free survival (DFS) and overall survival (OS) when
ZARNESTRA is administered after intensive induction and consolidation chemotherapy to adults
with poor risk acute myelogenous leukemia (AML) or high-risk myelodysplasia (MDS) in first
complete remission (CR).
I. To determine the tolerability and toxicities of ZARNESTRA when administered in a chronic
dosing schedule over a 48 week period to adults in first CR following intensive cytotoxic
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily on days 1-14. Treatment repeats every 21 days
for up to 16 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 14-44 patients will be accrued for this study within 11-15
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The trial is a success if greater than 45% of patients survive to 6 months. Comparing this to the null hypothesis of 25% survival, we have 84% power to detect this difference using an exact 2-sided binominal test of proportions for alpha of 0.10. This assumes no censoring occurs before 6 months.
Johns Hopkins University
United States: Food and Drug Administration
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