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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04179656
Recruitment Status : Not yet recruiting
First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Solid Tumor HER2 Gene Mutation HER-2 Gene Amplification HER-2 Protein Overexpression Drug: Pyrotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Pyrotinib Treatment
This arm for HER2-postive solid tumor
Drug: Pyrotinib
400 mg administered orally, once daily, continuously in 21 day cycles
Other Name: SHR1258




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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

  5. Safety (Adverse Events and Serious Adverse Events) [ Time Frame: up to 36 months ]
    From consent through 28 days following treatment completion (estimated 6 months)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179656


Contacts
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Contact: Haitao Wang (022)28331788 peterrock2000@126.com
Contact: LIli Wang

Locations
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China, Tianjin
Tianjin Medical University Second Hospital
Tianjin, Tianjin, China, 300211
Sponsors and Collaborators
Tianjin Medical University Second Hospital
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Haitao Wang Tianjin Medical University Second Hospital

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Responsible Party: Tianjin Medical University Second Hospital
ClinicalTrials.gov Identifier: NCT04179656    
Other Study ID Numbers: BP-HER2
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action