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Correlation Between Sorafenib Plasma Concentrations, Toxicity and Disease Control Rate in Patients Treated by Sorafenib for Hepatocellular Carcinoma

NCT02834546 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 143

Last updated 2020-04-29

No results posted yet for this study

Summary

The aim of this pilot study is to correlate the sorafenib plasma concentration to observed toxicity and to the disease control rate in 100 patients undergoing a palliative treatment of hepatocellular carcinoma (HCC). If some correlations are observed, we will consider planning a larger interventional study to adjust sorafenib daily dose to plasma concentration.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

BIOLOGICAL

Sorafenib plasma concentration 4 weeks after treatment initiation

Sorafenib plasma concentrations will be assessed at 4, 8 and 16 weeks by high performance liquid chromatography. The pharmacology Unit of Bordeaux university hospital (Pr Molimard) is a French Center of reference for the dosage of TKI in the plasma

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Eric FRISON, MD · Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2019-03-15
Completion
2019-03-15

Countries

  • France

Study Locations

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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 NCT02834546 on ClinicalTrials.gov