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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04179656
• Other study ID #: BP-HER2
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2019
• Est. completion date: December 2022

Study information

• Verified date: November 2019
• Source: Tianjin Medical University Second Hospital
• Contact: Haitao Wang
• Phone: (022)28331788
• Email: peterrock2000[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

1. Patients between the ages of 18 and 75;

2. ECOG physical status score 0-2 points;

3. The estimated total survival period is not less than 12 weeks;

4. Patients with HER2-positive solid tumors confirmed by pathology and identified as advanced tumors by clinicians or centers;

5. HER2 positive: refers to standard immunohistochemical staining (IHC) assay showing HER2 is 3+ and / or fluorescence in situ hybridization (FISH) positive or after second generation sequencing shows HER2 amplification and copy number = 3, or There is a HER2 activating mutation identified by the Molecular Oncology Committee (confirmed by the investigator at the test center) ;

6. Imaging studies have at least one measurable lesion with a diameter = 10 mm;

7. Pilotinib has not been used for the past 3 months;

8. The main organs function normally, they meet the following criteria:

1. Blood routine examination criteria are to comply with:

?.Hb=100 g/L; ?.ANC = 1.5 × 109 / L; ?.PLT=75×109 /L;

2. Biochemical tests are subject to the following criteria

?.TBIL = 1.5 × ULN (upper limit of normal value);

?.ALT and AST = 2.5 × ULN; if there is liver metastasis, ALT and AST = 5 × ULN;

?.Serum creatinine = 1.5 × ULN, creatinine clearance = 50ml / min (based on Cockroft and Gault formula);

3. Heart color ultrasound: Left ventricular ejection fraction (LVEF) = 50%;

9. The patient or his legal guardian understands the test procedure and content and signs an informed consent form (ICF) to provide true and effective information in accordance with the research and follow-up procedures;

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).

Related Conditions & MeSH terms

• HER-2 Gene Amplification
• HER-2 Protein Overexpression
• HER2 Gene Mutation
• Neoplasms
• Solid Tumor

Intervention

Drug:
• Pyrotinib
400 mg administered orally, once daily, continuously in 21 day cycles

Locations

Country	Name	City	State
China	Tianjin Medical University Second Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University Second Hospital	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Objective response rate defined as the patients confirmed complete response or partial response under RECIST 1.0 criteria.	at least 3 months
Secondary	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	up to 24 months
Secondary	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.	up to 24 months
Secondary	Disease Control Rate	Objective response rate defined as the patients confirmed complete response or partial response or stable disease under RECIST 1.0 criteria.	up to 24 months
Secondary	Overall Survival	Overall survival estimated using Kaplan-Meier methods is defined as the time from treatment initiation to death by any cause	up to 36 months
Secondary	Safety (Adverse Events and Serious Adverse Events)	From consent through 28 days following treatment completion (estimated 6 months)	up to 36 months