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

NCT02708667 | Unknown DMC

• 1 other identifier: 2015-FXY-078-Internal medicine
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

non-small cell lung cancer; crizotinib; hepatic toxicity

Outcome Measures

Primary Outcomes (1)

• number of patients with adverse events

  change from the date of taking crizotinib at 9 months

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed with stage III or IV non-small cell lung cancer (NSCLC), harbored ALK fusion gene and took crizotinib.

You may qualify if:

• patients who were histologically and cytologically confirmed NSCLC at stage III or IV
• harbored ALK fusion gene and took crizotinib
• age:18\~75years
• Eastern cooperative oncology group performance status(ECOG PS): 0\~2 points
• the expected lifetime is more than 12 weeks after being recruited

You may not qualify if:

• patients who also suffered from other malignant tumor
• uncontrolled systemic diseases,central nervous system (CNS) metastasis
• clinically active interstitial lung diseases
• severe liver dysfunction caused by hepatic cirrhosis or hepatitis （Child-Pugh class C, total index score 10-15 points）
• taking drugs that interact with crizotinib

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, biopsy tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Likun Chen

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Likun Chen

CONTACT

020-87342475; chenlk@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Associate chief physician

Study Record Dates

• First Submitted: March 5, 2016
• First Posted: March 15, 2016
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 15, 2016

Record last verified: 2016-03

Locations

CN (1)