Clinical trial NCT04179656: The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Solid Tumor
HER2 Gene Mutation
HER-2 Gene Amplification
HER-2 Protein Overexpression
Lead sponsor: Tianjin Medical University Second Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2019-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

      ①.Hb≥100 g/L; ②.ANC ≥ 1.5 × 109 / L; ③.PLT≥75×109 /L;
   2. 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);
   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).

Primary outcomes:
measure: Objective Response Rate
timeFrame: at least 3 months
Secondary outcomes:
measure: Progression free survival
timeFrame: up to 24 months
measure: Duration of Response
timeFrame: up to 24 months
measure: Disease Control Rate
timeFrame: up to 24 months
measure: Overall Survival
timeFrame: up to 36 months
measure: Safety (Adverse Events and Serious Adverse Events)
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Second Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Second Hospital
name: Haitao Wang
role: PRINCIPAL_INVESTIGATOR
References: