Study of Cipatinib in Patients With HER2 Positive or Uncertain Advanced Breast Cancer

Summary

Cipatinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the safety and tolerability of cipatinib in patients with HER2 positive or uncertain advanced breast cancer: 1. To evaluate the safety and tolerability of cipatinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) 2. To determine the pharmacokinetic profile of cipatinib and its metabolites 3. To assess preliminary antitumor activity 4. To determine preliminary regimen for phase II study 5. To determine the relation of expression of HER-1 and HER-2 to the antitumor activity.

Timeline

Start

2011-01

Primary completion

2012-11

Completion

2012-11

Drugs

Indications