Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib or Pyrotinib in combination with Docetaxel in patients with HER2 positive advanced gastric cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Pyrotinib oral daily, 240 mg, 320 mg, 400 mg.... Docetaxel i.v. once every 21 days.
Beijing Cancer Hospital, Peking University
Beijing, Beijing Municipality, China
RECRUITINGCancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChinese PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe maximum-tolerated dose (MTD) of Pyrotinib and that of Pyrotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
MTD will be defined as the maximum dose level at which no more than one subject out of three experience has a dose-limiting toxicity (DLT) upon completing one treatment cycle. DLT was defined as the certain AEs which were observed during the first cycle (D1-D21) of treatment
Time frame: 21 days
Cmax of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
Time frame: 12 months
Tmax of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
Time frame: 12 months
T1/2 of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
Time frame: 12 months
AUCss of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
Time frame: 12 months
R of Pyrotinib and Pytotinib with Docetaxel in patients with HER2 positive advanced gastric cancer
Time frame: 12 months
the number of participants with adverse event
Time frame: 12 months
preliminary antitumor activity for the regimen
Time frame: 12 months
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Cancer center, Sun Yet-sen University
Guangzhou, Guangdong, China
RECRUITING