Phase I Open-Label Study of the Safety, Toleration and Pharmacokinetics of CP-609,754, a Farnesyl Transferase Inhibitor, in Subjects With Advanced Malignant Tumors
OBJECTIVES: I. Determine the safety, tolerability, pharmacokinetics, and maximum tolerated
dose of CP-609,754 in patients with advanced solid tumors. II. Determine the predictability,
duration, intensity, onset, reversibility, and dose relationship of any observed toxicities
in these patients when treated with this regimen. III. Determine any preliminary evidence of
antitumor activity of this treatment as assessed by response rate and time to disease
progression in this patient population.
OUTLINE: This is a dose escalation study. Patients receive oral CP-609,754 1-2 times daily.
Treatment continues every 28 days for 12 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CP-609,754 until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 3 or 6 patients experience dose limiting toxicities. Patients are
followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 44-56 patients will be accrued for this study within 12
months.
Interventional
Primary Purpose: Treatment
Daniel M. Sullivan, MD
Study Chair
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
CDR0000068077
NCT00006085
June 2000
Name | Location |
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H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |