drugset / Trial / NCT02378389
Study Evaluating Pyrotinib/Pyrotinib in Combination With Docetaxel in Patients With HER2+ Advanced Gastric Cancer
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-09
- Primary completion
- 2016-08
- Completion
- 2017-08
Publications
- Liu D, Kou F, Gong J, Wang Z, Zhang X, Li J, Li Y, Li J, Zhou J, Lu M, Wang X, Lu Z, Cao Y, Zou J, Zhu X, Xu R, Shen L. Pyrotinib alone or in combination with docetaxel in refractory HER2-positive gastric cancer: A dose-escalation phase I study. Cancer Med. 2023 May;12(9):10704-10714. doi: 10.1002/cam4.5830. Epub 2023 Apr 20.
- Chen Z, Xu Y, Gong J, Kou F, Zhang M, Tian T, Zhang X, Zhang C, Li J, Li Z, Lai Y, Zou J, Zhu X, Gao J, Shen L. Pyrotinib combined with CDK4/6 inhibitor in HER2-positive metastatic gastric cancer: A promising strategy from AVATAR mouse to patients. Clin Transl Med. 2020 Aug;10(4):e148. doi: 10.1002/ctm2.148.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Pyrotinib | Small molecule | 240 mg | Oral |
| Subject | Pyrotinib | Small molecule | 320 mg | Oral |
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |
| Subject | Pyrotinib | Small molecule | 480 mg | Oral |
Indications
No indication recorded.