NCT03680183

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Non Small Cell Lung Cancer
• Hepatitis B

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-05-22
• Primary completion: 2019-03-01
• Completion: 2021-12-31
• First posted: 2018-09-21
• Last updated: 2018-09-28

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study