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

Phase 2

• Conditions: HER-2 Protein Overexpression; Solid Tumor; HER-2 Gene Amplification; HER2 Gene Mutation
• Interventions: Drug: Pyrotinib

• Registration Number: NCT04179656
• Lead Sponsor: Tianjin Medical University Second Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Study First Posted: 2019-11-27
• Last Update Posted: 2019-11-27
• Study Start: 2019-12
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1. There is a third interstitial fluid that cannot be controlled by drainage or other methods, such as pleural effusion and ascites;
2. It has many factors affecting the oral and absorption of drugs (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea and intestinal obstruction);
3. Those who have been confirmed to be allergic to the drug components of this program;
4. Patients who are known to be pregnant or planning to become pregnant, or gestational age patients who are unwilling to take effective contraceptive measures throughout the trial;
5. Patients with severe concomitant diseases or those considered by the investigator to be unsuitable for inclusion.
6. The investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of the study (for administrative reasons or for other reasons).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pyrotinib Treatment	Pyrotinib	This arm for HER2-postive solid tumor

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	at least 3 months	Objective response rate defined as the patients confirmed complete response or partial response under RECIST 1.0 criteria.

Secondary Outcome Measures

Name	Time	Method
Safety (Adverse Events and Serious Adverse Events)	up to 36 months	From consent through 28 days following treatment completion (estimated 6 months)
Progression free survival	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	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	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	up to 36 months	Overall survival estimated using Kaplan-Meier methods is defined as the time from treatment initiation to death by any cause

Trial Locations

Locations (1)

Tianjin Medical University Second Hospital; 🇨🇳 Tianjin, Tianjin, China