- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04179656
The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor
An Open-label, Phase 2 Study of Pyrotinib Maleate in Advanced Solid Tumors Patients With HER2( Erb-B2 Receptor Tyrosine Kinase 2)-Postive
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Haitao Wang
- Phone Number: (022)28331788
- Email: peterrock2000@126.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300211
- Tianjin Medical University Second Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- 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%;
- 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:
- 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;
- Patients with severe concomitant diseases or those considered by the investigator to be unsuitable for inclusion.
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Pyrotinib Treatment
This arm for HER2-postive solid tumor
|
400 mg administered orally, once daily, continuously in 21 day cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at least 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 24 months
|
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.
|
up to 24 months
|
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.
|
up to 24 months
|
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
|
up to 36 months
|
Safety (Adverse Events and Serious Adverse Events)
Time Frame: up to 36 months
|
From consent through 28 days following treatment completion (estimated 6 months)
|
up to 36 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP-HER2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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