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Residual Plasma Concentration of Sorafenib and Adverse Events in CHC (PharmacoCHC)

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ClinicalTrials.gov Identifier: NCT03340636
Recruitment Status : Unknown
Verified November 2017 by University Hospital, Caen.
Recruitment status was:  Not yet recruiting
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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Brief Summary:

To date, Sorafenib is the only drug therapy to have demonstrated a benefit in overall survival in patients with advanced or metastatic hepatocellular carcinoma. However, this treatment causes many adverse effects that may limit its prescription.

Under these conditions, predicting and therefore potentially preventing the adverse effects of sorafenib is a major issue in the management of patients with hepatocellular carcinoma treated with this drug.

Currently, there is little data available on the correlation between the pharmacokinetics of sorafenib and the side effects of this drug in patients treated for hepatocellular carcinoma.

Investigators propose an observational cohort study evaluating the correlation between residual plasma concentration of sorafenib and the risk of severe adverse effects (grades 3-5) in treatment in patients treated for hepatocellular carcinoma on cirrhosis.

This study should include 60 patients over an expected duration of 12 months. The aim of this work is to determine whether there is a correlation between the residual plasma concentration of sorafenib and the occurrence of severe adverse effects (grades 3-5) at treatment in patients treated for hepatocellular carcinoma on cirrhosis as well as potential influence of the etiology of cirrhosis on this relationship. The ultimate ambition is to be able to anticipate and thus prevent these adverse effects in order to increase the safety of the drug and potentially its effectiveness.


Condition or disease
Advanced or Metastatic Hepatocellular Carcinoma

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between the Residual Plasma Concentration of Sorafenib and the Occurrence of Adverse Events in Patients Treated for Hepatocellular Carcinoma
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. residual plasma concentration of sorafenib [ Time Frame: from baseline over 6 month ]
  2. occurrence of severe adverse effects (grades 3-5) [ Time Frame: from baseline over 6 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with underlying cirrhosis hepatocellular carcinoma treated with Sorafenib
Criteria

Inclusion Criteria:

  • Major Patients.
  • Patients with hepatocellular carcinoma on cirrhosis.
  • Patients treated for the first time with sorafenib for hepatocellular carcinoma.
  • Informed information about the study.

Exclusion Criteria:

  • Patients with contraindications to sorafenib.
  • Pregnant or lactating woman
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340636


Locations
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France
Caen University Hospital
Caen, France
Contact: Dupont Benoit, MD, PhD    02.31 06 45 40 ext +33    dupont-be@chu-caen.fr   
Principal Investigator: benoit Dupont, Md, PhD         
Sponsors and Collaborators
University Hospital, Caen
More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03340636    
Other Study ID Numbers: 16-109
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases