CP-609,754 in Treating Patients With Advanced Solid Tumors
Recruitment status was: Active, not recruiting
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of CP-609,754 in treating patients who have advanced solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||June 2000|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006085
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||Daniel M. Sullivan, MD||H. Lee Moffitt Cancer Center and Research Institute|