Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Status unconfirmed · Phase 1
Conditions studied: Breast Cancer, Gastric Cancer, Solid Tumors, NSCLC
In brief
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).
Key facts
- Study ID
- NCT02500199
- Run by
- Hengrui Therapeutics, Inc.
- People needed
- 50
- Starts
- 2015-06-01
- Expected to finish
- 2021-06-01
- Last updated by the study team
- 2021-02-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California, Irvine School of Medicine — Orange, California, United States
- UC Davis Comprehensive Cancer Center — Sacramento, California, United States
- Florida Cancer Specialists — Sarasota, Florida, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Washington University — St Louis, Missouri, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Tennessee Oncology — Nashville, Tennessee, United States
- South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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