The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor
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|ClinicalTrials.gov Identifier: NCT04179656|
Recruitment Status : Not yet recruiting
First Posted : November 27, 2019
Last Update Posted : November 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor HER2 Gene Mutation HER-2 Gene Amplification HER-2 Protein Overexpression||Drug: Pyrotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Phase 2 Study of Pyrotinib Maleate in Advanced Solid Tumors Patients With HER2( Erb-B2 Receptor Tyrosine Kinase 2)-Postive|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: Pyrotinib Treatment
This arm for HER2-postive solid tumor
400 mg administered orally, once daily, continuously in 21 day cycles
Other Name: SHR1258
- Objective Response Rate [ Time Frame: at least 3 months ]Objective response rate defined as the patients confirmed complete response or partial response under RECIST 1.0 criteria.
- Progression free survival [ Time Frame: up to 24 months ]Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression
- Duration of Response [ Time Frame: up to 24 months ]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.
- Disease Control Rate [ Time Frame: up to 24 months ]Objective response rate defined as the patients confirmed complete response or partial response or stable disease under RECIST 1.0 criteria.
- Overall Survival [ Time Frame: up to 36 months ]Overall survival estimated using Kaplan-Meier methods is defined as the time from treatment initiation to death by any cause
- Safety (Adverse Events and Serious Adverse Events) [ Time Frame: up to 36 months ]From consent through 28 days following treatment completion (estimated 6 months)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179656
|Contact: Haitao Wang||(022)firstname.lastname@example.org|
|Contact: LIli Wang|
|Tianjin Medical University Second Hospital|
|Tianjin, Tianjin, China, 300211|
|Principal Investigator:||Haitao Wang||Tianjin Medical University Second Hospital|