CLINICAL TRIALS PROFILE FOR PYROTINIB
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Clinical Trials for pyrotinib
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT01937689 ↗ | 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. |
| NCT01937689 ↗ | 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. |
| NCT02361112 ↗ | 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 |
| NCT02361112 ↗ | Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer | Completed | Jiangsu HengRui Medicine Co., Ltd. | 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 |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for pyrotinib
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Clinical Trial Sponsors for pyrotinib
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