Clinical Pharmacokinetics of TKIs in Chinese Patients of Hepatitis B (HBV)

Non Small Cell Lung Cancer Clinical Trial

Official title:

Clinical Pharmacokinetics of Tyrosine Kinase Inhibitors in Chinese Patients of Hepatitis B

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03680183
• Other study ID #: PTKI-HBV-01
• Status: Recruiting
• Start date: May 22, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2018
• Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Contact: Wenying Shu, PhD
• Phone: 86-20-66673666
• Email: 790840799[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study will explore the characteristics in clinical pharmacokinetics of gefitinib, erlotinib,afatinib,osimertinib, crizotinib, apatinib, icotinib in Chinese patients of Non-small-cell lung cancer and hepatitis B. The study is self-controlled. The plasma concentration of tyrosine kinase inhibitors will be analyzed before and after system treatment of HBV.

Description:

Tyrosine kinase inhibitors (TKIs) are first line treatment for non-small-cell lung cancer patients with mutations in targeted genes. TKIs are metabolized in liver into inactive metabolites before eliminating from body. Liver function might plays a significant role in inter-individual differences of pharmacokinetics of TKIs. Hepatitis B is a disease of high prevalence in south China. The liver function will be compromised if the infection of hepatitis B virus has not been controlled. This study aims to compare the pharmacokinetics of TKIs before and after controlling HBV with standard treatment in Chinese patients of non-small-cell lung cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2021
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• pathological confirmed non-small-cell lung cancer

• with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genetic mutation required by different TKIs

• liver function, ALT and/or AST <= 2*upper limit of normal (ULN)

• diagnosed of chronic hepatitis B

• Hepatitis B negative as controlled group

• receiving one type of TKIs

• Age between 18-70

Exclusion Criteria:

• diagnosed of acute/ active hepatitis B

• diagnosed of AIDS

• unable to make decision because of metastasis to central nervous system

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Hepatitis
• Hepatitis A
• Hepatitis B
• Non Small Cell Lung Cancer

Intervention

Drug:
• Entecavir 1Mg Oral Tablet
The anti-HBV treatment includes a anti-HBV antibiotics and a drug of protecting liver cells or decrease alanine aminotransferase (ALT) or aspartate transaminase (AST)

Locations

Country	Name	City	State
China	Affiliated Cancer Hospital & Institute of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average plasma concentration of the drugs (TKIs)	compare the concentration of TKIs prior to and after anti-HBV treatment	one year after recruit
Secondary	Incidence of adverse reaction caused by TKIs	the adverse reaction of TKIs before and after anti-HBV treatment	one year after recruit