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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02708667
• Other study ID #: 2015-FXY-078-Internal medicine
• Status: Recruiting
• Phase: N/A
• First received: March 5, 2016
• Last updated: March 9, 2016
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: March 2016
• Source: Sun Yat-sen University
• Contact: Likun Chen
• Phone: 020-87342475
• Email: chenlk[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with adverse events		change from the date of taking crizotinib at 9 months	Yes
Secondary	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	No