Pharmacokinetics of Paclitaxel in Correlation With Adverse Events in Cancer Patients With and Without Liver Impairment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Liver Diseases
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 bi...
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.
Tracking Information
- NCT #
- NCT04863144
- Collaborators
- Not Provided
- Investigators
- Study Director: Ahmed Nour-Eldin, Professor Pharmacology Department - Faculty of Medicine - Ain Shams University Study Director: Khaled Abdel-Aziz, MD Oncology Department - Faculty of Medicine - Ain Shams University