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

NCT04863144 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-04-28

No results posted yet for this study

Summary

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

Conditions

Interventions

OTHER

Blood samples

Plasma concentrations of paclitaxel and its metabolites will be obtained during the first treatment cycle. The samples for paclitaxel analysis will be collected in ethylenediamine tetraacetic acid tubes at 7-time points: just before infusion, in the middle of the infusion, at the end of infusion, at 1, 2, 4 and 6 hours post-infusion.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ahmed Nour-Eldin, Professor · Pharmacology Department - Faculty of Medicine - Ain Shams University

  • Khaled Abdel-Aziz, MD · Oncology Department - Faculty of Medicine - Ain Shams University

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-12-01
Completion
2022-02-01

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04863144 on ClinicalTrials.gov