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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Cipatinib either at 200, 400, 800, 1200, 1400, 1600 or 1800 mg, p.o. once daily
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The maximum-tolerated dose (MTD) regimen of cipatinib will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) after completing one treatment cycle.
Time frame: 3 weeks
Number of participants with adverse events.
Time frame: 6 weeks
Cipatinib pharmacokinetic parameters may include AUC, Cmax, Tmax, and t1/2.
Time frame: 3 weeks
Objective response rate (ORR).
Time frame: 6 weeks
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