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

November 25, 2019 updated by: Tianjin Medical University Second Hospital

An Open-label, Phase 2 Study of Pyrotinib Maleate in Advanced Solid Tumors Patients With HER2( Erb-B2 Receptor Tyrosine Kinase 2)-Postive

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Tianjin
      • Tianjin, Tianjin, China, 300211
        • Tianjin Medical University Second Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • SHR1258

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

November 25, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (ACTUAL)

November 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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