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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
400 mg administered orally, once daily, continuously in 21 day cycles
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China
Objective Response Rate
Objective response rate defined as the patients confirmed complete response or partial response under RECIST 1.0 criteria.
Time frame: at least 3 months
Progression free survival
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression
Time frame: up to 24 months
Duration of Response
The first evaluation of treatment efficacy is the time fromcomplete response or partial response to the first assessment of disease progression or death from any cause.
Time frame: up to 24 months
Disease Control Rate
Objective response rate defined as the patients confirmed complete response or partial response or stable disease under RECIST 1.0 criteria.
Time frame: up to 24 months
Overall Survival
Overall survival estimated using Kaplan-Meier methods is defined as the time from treatment initiation to death by any cause
Time frame: up to 36 months
Safety (Adverse Events and Serious Adverse Events)
From consent through 28 days following treatment completion (estimated 6 months)
Time frame: up to 36 months
LIli Wang
CONTACT
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