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