Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Breast Cancer
- Gastric Cancer
- NSCLC
- Solid Tumors
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an open-label, dose escalation study of repeated doses of pyrotinib in patients with HER2-positive advanced solid tumors, including breast cancer, non small cell lung cancer. Part 1 of the trial is dose escalation and is designed to enroll 3 to 6 patients in each dose group. Adverse events (...
This is an open-label, dose escalation study of repeated doses of pyrotinib in patients with HER2-positive advanced solid tumors, including breast cancer, non small cell lung cancer. Part 1 of the trial is dose escalation and is designed to enroll 3 to 6 patients in each dose group. Adverse events (AEs) will be assessed and monitored throughout the study. Dose-limiting toxicities (DLT) will be assessed from the first dose of study drug through day 28 in the first cycle of treatment. Part 2 of the trial will consist of two independent arms: arm A for HER2 positive mBC and arm B for NSCLC with documented HER2 mutation will be investigated to further evaluate safety and the preliminary effectiveness and clinical benefits of pyrotinib as a single agent.
Tracking Information
- NCT #
- NCT02500199
- Collaborators
- Not Provided
- Investigators
- Study Director: Junsheng Wang, MD Hengrui Therapeutics, Inc.
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