Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer
Completed
Chinese Academy of Medical Sciences
Phase 1
Pyrotinib 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 Pyrotinib in patients with HER2
positive advanced breast cancer:
- To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose
(MTD)
- To determine the dose-limiting toxicity (DLT)
- To determine the pharmacokinetic profile of Pyrotinib and its metabolites
- To assess preliminary antitumor activity
- To determine preliminary regimen dose for phase II study
- To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer
Completed
Jiangsu HengRui Medicine Co., Ltd.
Phase 1
Pyrotinib 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 Pyrotinib in patients with HER2
positive advanced breast cancer:
- To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose
(MTD)
- To determine the dose-limiting toxicity (DLT)
- To determine the pharmacokinetic profile of Pyrotinib and its metabolites
- To assess preliminary antitumor activity
- To determine preliminary regimen dose for phase II study
- To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer
Completed
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase 1
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 in combination with
capecitabine in patients with HER2 positive metastatic breast cancer:
To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To
determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of
Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for
phase II study
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