Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC 710086D) in Solid Tumors
I. Determine the maximum tolerated dose of BMS-214662 in patients with solid tumors.
II. Evaluate intermediate biological endpoints as surrogates for the effectiveness of this
drug in these patients.
III. Determine the nature of dose limiting toxicity of this drug in this patient population.
IV. Determine the recommended phase II regimen of this drug in these patients. V. Establish
a pharmacologic and pharmacokinetic profile of this drug in these patients.
OUTLINE: This is a dose escalation study.
Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every
6 weeks in the absence of disease progression or unacceptable toxicity.
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 at which 2 of 6 patients experience
dose limiting toxicities.
Patients are followed every 3 months for at least 24 months.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD, defined as the dose level among the 9 levels studied having toxicity rate closest to a target of 33%, graded according to CTC version 2.0
Toxicity is defined as grade 3, 4 non-hematologic and grade 4 hematologic (neutropenia and thrombocytopenia) toxicity. The continual reassessment method (CRM) will be used.
Up to 6 weeks
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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