NCT04179656

The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor

An Open-label, Phase 2 Study of Pyrotinib Maleate in Advanced Solid Tumors Patients With HER2( Erb-B2 Receptor Tyrosine Kinase 2)-Postive

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, Phase 2 study exploring the efficacy and safety of 马来酸Pyrotinib Maleate Tablets in patients with solid tumors with activating（harmful） HER2 mutations or with HER2 gene amplification or immunohistochemical staining (IHC) assay showing HER2 is 3+ and / or fluorescence in situ hybridization (FISH) positive.

Conditions

• Solid Tumor
• HER2 Gene Mutation
• HER-2 Gene Amplification
• HER-2 Protein Overexpression

Interventions

Type	Name	Description
DRUG	Pyrotinib	400 mg administered orally, once daily, continuously in 21 day cycles

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2019-11-27
• Last updated: 2019-11-27

Locations

1 site across 1 country: China