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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02708667

Enrollment

Registered

2016-03-15

Start date

2015-09-30

Completion date

2016-05-31

Last updated

2016-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

non-small cell lung cancer, crizotinib, hepatic toxicity

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
number of patients with adverse events	change from the date of taking crizotinib at 9 months

Secondary

Measure	Time frame
progression free survival	from the date of taking crizotinib to the date of objective tumor progression or date of death from any cause,whichever came first,assessed up to 48 months

Countries

China

Contacts

Primary ContactLikun Chen

chenlk@sysucc.org.cn020-87342475

Outcome results