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Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02535507
Recruitment Status : Unknown
Verified August 2015 by Caicun Zhou, Tongji University.
Recruitment status was:  Recruiting
First Posted : August 28, 2015
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):
Caicun Zhou, Tongji University

Brief Summary:
Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced Non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Pyrotinib Phase 2

Detailed Description:

This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced pre-treated Non-small cell lung cancer.

To observe objective response rate (ORR) of pyrotinib in HER2 positive NSCLC. To observe Progression free survival (PFS). To assess the overall survival (OS). To assess side effects. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Pyrotinib as a Single Agent in HER2 Mutation Advanced Non-small Cell Lung Cancer Patients Who Failed to Previous at Least 2nd Line Treatments
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Pyrotinib treatment arm
pyrotinib treatment arm
Drug: Pyrotinib
Drug: Pyrotinib pyrotinib, single agent, 400mg p.o once daily until disease progressed




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: tumor assessment every 6-8 weeks after the initiation of pyrotinib, up to 24 months ]
    To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 24 months ]
    PFS is evaluated in 24 months since the treatment began


Other Outcome Measures:
  1. overall survival [ Time Frame: 24 months ]
    evaluated in the 24th month since the treatment began

  2. Safety and Tolerability [ Time Frame: 24 months ]
    Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0

  3. quality of life (measured by questionnaire) [ Time Frame: 24 months ]
    Change from baseline in Pain on the 11 point short pain scale (SPS-11)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged ≥18 and ≤80 years.
  • ECOG performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • At least one measurable lesion exists.(RECIST 1.1)
  • Histologically or cytologic confirmed HER2 positive advanced Non-small cell lung cancer who failed prior therapies.
  • Required laboratory values including following parameters:

ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms

  • Signed informed consent.

Exclusion Criteria:

  • Subjects with third space fluid that can not be controled by drainage or other methods.
  • Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
  • Less than 4 weeks from the last radiotherapy,chemotherapy,target therapy
  • Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  • Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
  • Receiving any other antitumor therapy.
  • Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).
  • History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  • Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
  • Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
  • Known history of neurological or psychiatric disease, including epilepsy or dementia.

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): NCT02535507


Contacts
Contact: Caicun Zhou, MD,PhD 86-65115006-3050 caicunzhoudr@126.com

Locations
China
Department of Oncology, Shanghai pulmonary hospital Recruiting
Shanghai, China, 200433
Contact: Caicun zhou, MD, PhD    86-65115006-3050    caicunzhoudr@126.com   
Contact: shengxiang Ren, MD,PhD       harry_ren@126.com   
Sub-Investigator: Shengxiang Ren, MD,PhD         
Sub-Investigator: Fengying Wu, MD,         
Sub-Investigator: Xiaoxia Chen, MD,PhD         
Sub-Investigator: Chunxia Su, MD,PhD         
Principal Investigator: Caicun Zhou, MD,PhD         
Sponsors and Collaborators
Tongji University
Investigators
Principal Investigator: Caicun Zhou, MD,PhD Shanghai Pulmonary Hospital, Tongji University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Caicun Zhou, MD,PhD, Tongji University
ClinicalTrials.gov Identifier: NCT02535507     History of Changes
Other Study ID Numbers: FK1406
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by Caicun Zhou, Tongji University:
pyrotinib
HER2
Non-small Cell Lung Cancer
Phase II

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms