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

Trial Profile

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

Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Aug 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.
  • Most Recent Events

    • 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.
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