A Two-part Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pyrotinib in Patients With HER2-positive Solid Tumors Whose Disease Progressed on Prior HER2 Targeted Therapy
Phase of Trial: Phase I
Latest Information Update: 16 Nov 2017
At a glance
- Drugs Pyrotinib (Primary)
- Indications Advanced breast cancer; Gastric cancer; Non-small cell lung cancer; Solid tumours
- Focus Adverse reactions; Therapeutic Use
- Sponsors Hengrui Therapeutics; Jiangsu Hengrui Medicine Co.
- 08 Aug 2017 Planned number of patients changed from 70 to 50.
- 28 Jun 2017 Planned End Date changed from 1 Mar 2018 to 1 Mar 2020.
- 28 Jun 2017 Planned primary completion date changed from 1 Dec 2017 to 1 Dec 2019.