CP-724,714 in Treating Patients With Metastatic Breast Cancer
RATIONALE: CP-724,714 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase I trial to study the effectiveness of CP-724,714 in treating patients who have metastatic HER2-overexpressing breast cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Safety and Pharmacokinetic/Pharmacodynamic Study of CP-724, 714 In Patients With Metastatic HER2-Overexpressing Breast Cancer|
|Study Start Date:||January 2003|
|Study Completion Date:||May 2005|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
- Determine the safety and tolerability of CP-724,714 in patients with metastatic HER2-overexpressing breast cancer.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine, preliminarily, any antitumor activity of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the relationship of drug-related adverse events to pharmacokinetic exposure parameters in these patients.
- Determine the relationship of changes in serum HER2 extracellular domain and HER2 receptor tyrosine kinase phosphorylation to pharmacokinetic exposure parameters and clinical outcome in patients treated with this drug.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral CP-724,714 on days 1 and 3-21 during course 1 and then daily during subsequent courses. Courses repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CP-724,714 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 6 months.
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Carolyn Britten, MD||Jonsson Comprehensive Cancer Center|