Phase I Trial of R115777 (NSC 702818) in Relapsed, Refractory or High Risk Myeloid Leukemia
I. To define the maximum tolerated dose (MTD) of R115777 (tipifarnib) in patients with
relapsed, refractory, or high risk myeloid leukemias treated according to this regimen.
II. To assess the toxicity and preliminary assessment of efficacy of R115777 in patients
with relapsed, refractory, or high risk myeloid leukemias.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral tipifarnib twice daily on days 1-7 and 15-21. Courses repeat every 28
days in the absence of unacceptable toxicity or disease progression. Patients achieving a
complete response (CR) receive 2 additional courses beyond CR. Patients experiencing relapse
after previously achieving CR may receive additional tipifarnib at the current dose level
for newly registered patients.
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the MTD is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
Patients are followed every 6 months for survival.
PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the highest dose level in which six patients have been evaluated for toxicity with no more than one patient experiencing dose limiting toxicity (DLT) assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
The toxicities observed at each dose level will be summarized in terms of type, severity, time of onset, duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.
Beckman Research Institute
United States: Food and Drug Administration
|City of Hope||Duarte, California 91010|