Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC 710086) in Acute Leukemias, Myelodysplastic Syndromes (RAEB and RAEB-T) and Chronic Myeloid Leukemia in Blast Phase
I. Determine the maximum tolerated dose and dose limiting toxicity of BMS-214662 in patients
with acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia in blast phase.
II. Determine any preliminary evidence of antileukemia activity of this drug in these
OUTLINE: This is a dose escalation study.
Patients receive BMS-214662 IV over 1 hour weekly for 4 weeks. Treatment continues every 4
weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease
Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 10 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose preceding that at which 2 of 6 patients experience DLT assessed using NCI CTC version 2.0
Non-parametric tests will be used to study the relationship between baseline and post-therapy values at different dose levels and times.
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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