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

NCT04179656 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-11-27

No results posted yet for this study

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

DRUG

Pyrotinib

400 mg administered orally, once daily, continuously in 21 day cycles

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Tianjin Medical University Second Hospital

    lead OTHER

Principal Investigators

  • Haitao Wang · Tianjin Medical University Second Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04179656 on ClinicalTrials.gov