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Pharmacokinetics of Paclitaxel in Correlation With Adverse Events in Cancer Patients With and Without Liver Impairment

Liver Diseases Clinical Trial

Official title:
Effect of CYP3A4 and CYP2C8 Activity on Pharmacokinetics of Paclitaxel, Correlation With Adverse Events in Cancer Patients With and Without Liver Impairment

Clinical Trial Summary

The study aims to assess the pharmacokinetics of paclitaxel and its two major metabolites in patients with normal and impaired liver functions.

Clinical Trial Description

population pharmacokinetic study in patients with normal or impaired liver functions, receiving paclitaxel for cancer treatment. 40 Patients with histologically confirmed solid tumors will be enrolled in the study: - 20 patients have normal liver functions as defined by transaminase < 2.6 x ULN and bilirubin values < 1.26 x ULN. - 20 patients with liver impairment as defined by transaminase 2.6 - 10 x ULN and bilirubin values 1.26 - 5 x ULN. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04863144
Study type Observational
Source Ain Shams University
Contact Ahmed M Mohamed, Master
Phone 01126109080
Email dr_ahmed_mostafa@med.asu.edu.eg
Status Recruiting
Phase
Start date August 1, 2020
Completion date February 1, 2022
View Details
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