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A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02834936
Recruitment Status : Unknown
Verified March 2017 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 15, 2016
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:

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

To observe objective response rate (ORR) of pyrotinib in NSCLC With HER2 Mutation. To observe Progression free survival (PFS). To assess the overall survival (OS).

A secondary aim is to obtain safety information.

To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Drug: pyrotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Clinica Study: Efficacy and Safety of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
Study Start Date : September 27, 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pyrotinib treatment Drug: pyrotinib
Other Name: BLTN




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: tumor assessment every 6-9 weeks after the initiation of pyrotinib, up to 24 months ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: up to 24 months ]
  2. Incidence and Intensity of Adverse Events [ Time Frame: From signing informed consent document until 28 days after the last drug administration ]
    Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0



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. ECOG performance status of 0 to 1.
  2. Life expectancy of more than 3 months.
  3. At least one measurable lesion exists.(RECIST 1.1).
  4. Histologically or cytologic confirmed Non-small cell lung cancer, Phase IIIB or IV according to IASLC 2009.
  5. Failed prior therapies.(RECIST 1.1).
  6. Confirmed HER2 mutation by Central Laboratory。
  7. More than one prior Platinum based chemotherapy for advanced and/or metastatic, or recurrent NSCLC in neoadjuvant or adjuvant chemotherapy.
  8. Required laboratory values including following parameters:

    ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 90 x 10^9/L; Hemoglobin: ≥ 90 g/L; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤2 x ULN or ALT and AST: ≤5x ULN for patients with liver metastasis; BUN and Cr: ≤1.5 x ULN; creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: < 470 ms for female and < 450 ms for male.

  9. Signed informed consent

Exclusion Criteria:

  1. Previous therapy with other HER2 inhibitors.
  2. History of severe hypersensitivity reactions to the excipients of the trial drugs.
  3. Have clinically significant cavity effusion,such as pleural effusion、 pericardial effusion or ascites and require clinical intervention
  4. Active brain metastases
  5. Other malignancy within the past (including primary brain tumor or Leptomeningeal tumor), other than basal cell skin cancer or carcinoma in situ of the cervix
  6. Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1)
  7. Treatment with surgery, chemotherapy, radiotherapy or other target therapy within the past 4 weeks before start of therapy
  8. Uncontrolled hypertensin,diabetes.
  9. unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure>NYHA II, serious cardiac arrhythmia
  10. Active infection
  11. Variety of factors that affect the oral medication (such as unable to swallow, chronic diarrhea, bowel obstruction and other gastrointestinal disorders or abnormalities
  12. History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  13. 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.
  14. Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
  15. Known history of neurological or psychiatric disease, including epilepsy or dementia.
  16. Treatment in another clinical trial within the past 4 weeks before start of therapy
  17. Any of the other conditions of which researchers believe that the patient is not fit to take part in the study.

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): NCT02834936


Locations
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China, Shanghai
Shanghai Pulmonary Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Caicun Zhou, M. D.       caicunzhoudr@126.com   
China
HR-BLTN-II-NSCLC Investigational Site Recruiting
Beijing, China
Contact: Jiangang Yu    18036618602    yujiangang@shhrp.com   
HR-BLTN-II-NSCLC Investigational Site Recruiting
Changsha, China
Contact: Jiangang Yu    18036618602    yujiangang@shhrp.com   
HR-BLTN-II-NSCLC Investigational Site Not yet recruiting
Guangzhou, China
HR-BLTN-II-NSCLC Investigational Site Recruiting
Hangzhou, China
Contact: Jiangang Yu    18036618602    yujiangang@shhrp.com   
HR-BLTN-II-NSCLC Investigational Site Recruiting
Harbin, China
Contact: Jiangang Yu    18036618602    yujiangang@shhrp.com   
HR-BLTN-II-NSCLC Investigational Site Recruiting
Nanjing, China
Contact: Jiangang Yu    18036618602    yujiangang@shhrp.com   
HR-BLTN-II-NSCLC Investigational Site Not yet recruiting
Shanghai, China
Contact: Jiangang Yu    18036618602    yujiangang@shhrp.com   
HR-BLTN-II-NSCLC Investigational Site Recruiting
Suzhou, China
Contact: Jiangang Yu    18036618602    yujiangang@shhrp.com   
HR-BLTN-II-NSCLC Investigational Site Not yet recruiting
Wuhan, China
HR-BLTN-II-NSCLC Investigational Site Recruiting
Zhengzhou, China
Contact: Jiangang Yu    18036618602    yujiangang@shhrp.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02834936    
Other Study ID Numbers: HR-BLTN-Ⅱ-NSCLC
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The plan havn't been decided
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases