An Observational Research Of Crizotinib’s Hepatic Toxicity In Non-small Cell Lung Cancer Patients

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Brief Title

An Observational Research Of Crizotinib's Hepatic Toxicity In Non-small Cell Lung Cancer Patients

Official Title

An Observational Research on Relationship Between c-Met Gene Polymorphism, Promoter Methylation Level, Related Drug Metabolism Enzymes and Crizotinib's Hepatic Toxicity in Non-small Cell Lung Cancer Patients

Brief Summary

      Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug
      Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung
      cancer (NSCLC) and its administration has achieved considerable success. However, adverse
      effects inevitably occurred and the most common one was hepatic toxicity, appearing as
      elevating alanine aminotransferase(ALT) and aspartate aminotransferase(AST). Therefore, the
      investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and
      explore whether there is any biological marker to diagnose this side effect in an early
      stage, which may realize individualized therapy with more efficacy and less side effects.
    



Study Type

Observational


Primary Outcome

number of patients with adverse events

Secondary Outcome

 progression free survival

Condition

Non-Small Cell Lung Cancer



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

50

Start Date

September 2015

Completion Date

May 2016

Primary Completion Date

May 2016

Eligibility Criteria

        Inclusion Criteria:

          1. patients who were histologically and cytologically confirmed NSCLC at stage III or IV

          2. harbored ALK fusion gene and took crizotinib

          3. age:18~75years

          4. Eastern cooperative oncology group performance status(ECOG PS): 0~2 points

          5. the expected lifetime is more than 12 weeks after being recruited

        Exclusion Criteria:

          1. patients who also suffered from other malignant tumor

          2. uncontrolled systemic diseases,central nervous system (CNS) metastasis

          3. clinically active interstitial lung diseases

          4. severe liver dysfunction caused by hepatic cirrhosis or hepatitis (Child-Pugh class C,
             total index score 10-15 points)

          5. taking drugs that interact with crizotinib
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Likun Chen, 020-87342475, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02708667

Organization ID

2015-FXY-078-Internal medicine


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

Likun Chen, Principal Investigator, Sun Yat-sen University


Verification Date

March 2016