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

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT02708667
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2016-03
• Study First Submitted: 2016-03-05
• Study First Submitted QC: 2016-03-09
• Last Update Submitted: 2016-03-09
• Study First Posted: 2016-03-15
• Last Update Posted: 2016-03-15
• Primary Completion: 2016-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China