NCT05274191

An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zhongshan Hospital Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

A single arm, open-label Phase II clinical study.The subjects were patients with lung, gastric and colorectal cancers.

Detailed description

Object: 1.The main purpose: T To observe and evaluate the efficacy of pyrotinib in patients with HER2-mutated/amplified metastatic solid tumors after failure of standard therapy; 2. Secondary objectives: To observe and evaluate the safety of pyrotinib in patients in HER2 mutated or amplified metastatic solid tumors after failure of standard treatment.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Pyrotinib Maleate	Pyrotinib ± standard regimen Pyrotinib: 400 mg/day (once a day, orally at the same time every day), continued until disease progression;
OTHER	standard regimen	standard regimen

Timeline

• Start date: 2022-03-04
• Primary completion: 2022-03-15
• Completion: 2024-03-15
• First posted: 2022-03-10
• Last updated: 2022-03-10