Breast Cancer Clinical Trial
Official title:
A Phase I Safety and Pharmacokinetic/Pharmacodynamic Study of CP-724, 714 In Patients With Metastatic HER2-Overexpressing 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.
OBJECTIVES:
- 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.
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