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

NCT04179656 | Unknown Phase 2

• 1 other identifier: BP-HER2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor; HER2 Gene Mutation; HER-2 Gene Amplification; HER-2 Protein Overexpression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Progression free survival

  up to 24 months

• Duration of Response

  up to 24 months

• Disease Control Rate

  up to 24 months

• Overall Survival

  up to 36 months

• Safety (Adverse Events and Serious Adverse Events)

  up to 36 months

Study Arms (1)

Pyrotinib Treatment

EXPERIMENTAL

This arm for HER2-postive solid tumor

Drug: Pyrotinib

Interventions

Pyrotinib DRUG

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

Also known as: SHR1258

Pyrotinib Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18 and 75;
• ECOG physical status score 0-2 points;
• The estimated total survival period is not less than 12 weeks;
• Patients with HER2-positive solid tumors confirmed by pathology and identified as advanced tumors by clinicians or centers;
• 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) ;
• Imaging studies have at least one measurable lesion with a diameter ≥ 10 mm;
• Pilotinib has not been used for the past 3 months;
• The main organs function normally, they meet the following criteria:
• Blood routine examination criteria are to comply with:
• ①.Hb≥100 g/L; ②.ANC ≥ 1.5 × 109 / L; ③.PLT≥75×109 /L;
• Biochemical tests are subject to the following criteria
• ①.TBIL ≤ 1.5 × ULN (upper limit of normal value);
• ②.ALT and AST ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN;
• ③.Serum creatinine ≤ 1.5 × ULN, creatinine clearance ≥ 50ml / min (based on Cockroft and Gault formula);
• Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 50%;

You may not qualify if:

• There is a third interstitial fluid that cannot be controlled by drainage or other methods, such as pleural effusion and ascites;
• It has many factors affecting the oral and absorption of drugs (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea and intestinal obstruction);
• Those who have been confirmed to be allergic to the drug components of this program;
• 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;
• 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).

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, 300211, China

Location

MeSH Terms

Interventions

pyrotinib

Study Officials

• Haitao Wang

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haitao Wang

CONTACT

(022)28331788; peterrock2000@126.com

LIli Wang

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

CN (1)