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 |
| NCT02378389 ↗ | Study Evaluating Pyrotinib/Pyrotinib in Combination With Docetaxel in Patients With HER2+ Advanced Gastric Cancer | Unknown status | 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 or Pyrotinib in combination with Docetaxel in patients with HER2 positive advanced gastric cancer. |
| NCT02422199 ↗ | A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab | Unknown status | Jiangsu HengRui Medicine Co., Ltd. | Phase 1/Phase 2 | Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin, taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab and randomized in a 1:1 ratio to one of the following treatment arms: - Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily) - Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients will receive either arm of therapy until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion. |
| NCT02500199 ↗ | Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors | Active, not recruiting | Hengrui Therapeutics, Inc. | Phase 1 | Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors (metastatic breast cancer, gastric cancer, or other solid tumors that have no targeted agent as standard of care). Part 2: to estimate the overall response rate (ORR) for patients with HER2-positive metastatic breast cancer (mBC) and HER2 mutant non-small cell lung cancer (NSCLC) treated at the RP2D (or MTD). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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