TARGETed Therapy Drug MONITOring in DIGestive Oncology

Last updated: March 25, 2025
Sponsor: UNICANCER
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stomach Cancer

Gastric Ulcers

Liver Disorders

Treatment

Blood sampling to build population pharmacokinetics model

Clinical Study ID

NCT05443087
UC-GIG-2104
2021-A01724-37
  • Ages > 18
  • All Genders

Study Summary

Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic colorectal cancer (mCRC), hepatocellular carcinoma (HCC), gastroenteropancreatic neuroendocrine tumor (gepNET), or pancreatic neuroendocrine tumor (pNET)), with the aim of determine the optimal dose adapted for each patient, in the future.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient aged 18 years or over

  2. Advanced digestive cancer (histologically confirmed or confirmed by imaging for HCC)for which a standard treatment (according to each drug SmPC and as per standard ofcare) planned with:

  • Regorafenib for GIST, mCRC, and HCC,

  • Everolimus for gepNET,

  • Sunitinib for pNET or GIST,

  • Cabozantinib for HCC,

  • Encorafenib - cetuximab for mCRC

  1. Life expectancy of greater than 3 months - at the discretion of the investigator

  2. Measurable disease according to tumor evaluation criteria as per local practice (Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, etc.)

  3. Patients must be affiliated to a Social Security System (or equivalent)

  4. Patient must have signed a written informed consent form prior to any trial specificprocedures. When the patient is physically unable to give their written consent, atrusted person of their choice, independent from the investigator or the sponsor,can confirm in writing the patient's consent.

Exclusion

Exclusion Criteria:

  1. Other concomitant anticancer systemic treatment (chronic chemotherapy, antitumorhormone therapy or immunotherapy) than the one studied

  2. Unresolved toxicity higher than NCI-CTCAE v5.0 Grade 1 attributed to any priortherapy/procedure excluding alopecia and peripheral neuropathy

  3. Prior treatment with the same MKI molecule(s) planned to be given in the cohort. Ifdifferent MKI molecules (from the one(s) planned in the study) have been previouslytaken, a wash out period of 2 weeks before treatment should be observed.

  4. Other invasive malignancies either currently active or active in the last 3 years,except adequately treated in situ carcinoma of the cervix and basal or squamous cellcarcinoma of the skin

  5. Any condition that may jeopardize patient participation in the study as well as noncontraception for male and female with child-bearing potential, pregnancy or breastfeeding.

  6. Patient unwilling or unable to comply with the medical follow-up required by thestandard treatment taken (including PK sampling during treatment phase and vitalstatus collection during follow-up phase) because of psychosocial, familial, socialor geographical reasons

  7. Participation in another clinical study with an investigational medicinal productduring the last 30 days prior to inclusion and during the present study (except ifpatient is included in the control arm, with placebo or with a product which have amarketed authorisation, used as per the SmPC for the given indication)

  8. Patient deprived of their liberty or under protective custody or guardianship

Study Design

Total Participants: 330
Treatment Group(s): 1
Primary Treatment: Blood sampling to build population pharmacokinetics model
Phase:
Study Start date:
August 29, 2022
Estimated Completion Date:
June 30, 2027

Study Description

Phase IV, national, multicenter, open, multi-cohort interventional study:

  1. Regorafenib - mCRC, GIST, and HCC = 3x30 = 90 patients

  2. Everolimus - gepNET = 60 patients

  3. Sunitinib - pNET and GIST = 60 patients

  4. Cabozantinib - HCC = 60 patients

  5. Encorafenib-cetuximab - mCRC = 60 patients

The patients included will be treated and followed according to standard practice (national recommendations and according to the summary of product characteristics (SmPC) of each molecule). According to the cohort, a maximum of 1 to 2 blood tubes will be taken at different times during the study: at baseline, then 1 month after the start of treatment, then 2 months after the start of treatment, if an adverse event of specific interest (AESI) occurs, and in case of progressive disease.

Connect with a study center

  • CHU d'Amiens Pcardie - Hopital Sud

    Amiens,
    France

    Active - Recruiting

  • CH d'Auxerre

    Auxerre,
    France

    Active - Recruiting

  • Institut du Cancer Avignon - Institut Sainte Catherine

    Avignon,
    France

    Site Not Available

  • CH de Bayeux - Onconormandie

    Bayeux,
    France

    Site Not Available

  • Centre Jean Perrin

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Hôpital Beaujon APHP

    Clichy,
    France

    Active - Recruiting

  • Centre Georges Francois Leclerc

    Dijon,
    France

    Site Not Available

  • Institut de Cancérologie de Bourgogne

    Dijon,
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille,
    France

    Active - Recruiting

  • Groupement des hôpitaux de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul

    Lille,
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon,
    France

    Site Not Available

  • Hôpital Européen Marseille

    Marseille,
    France

    Site Not Available

  • CHRU de Nancy - Hôpital de Brabois Adulte

    Nancy,
    France

    Active - Recruiting

  • CHU de Nantes - Hôtel Dieu

    Nantes,
    France

    Active - Recruiting

  • Centre Antoine Lacassagne

    Nice,
    France

    Site Not Available

  • APHP Pitié Salpétrière

    Paris,
    France

    Active - Recruiting

  • Hôpital Saint Joseph

    Paris,
    France

    Active - Recruiting

  • Institut Mutualiste de Montsouris

    Paris,
    France

    Active - Recruiting

  • Hôpital Privé des Côtes d'Armor - SAS

    Plérin,
    France

    Active - Recruiting

  • CHU de Poitiers

    Poitiers,
    France

    Site Not Available

  • CHU de Reims - Hôpital Robert Debré

    Reims,
    France

    Active - Recruiting

  • Institut Jean Godinot

    Reims,
    France

    Active - Recruiting

  • Centre Eugène Marquis

    Rennes,
    France

    Site Not Available

  • CHU Rouen - Hôpital Charles Nicolle

    Rouen,
    France

    Active - Recruiting

  • CH Saint Malo - Hôpital Broussais

    Saint-Malo,
    France

    Active - Recruiting

  • ICANS

    Strasbourg,
    France

    Active - Recruiting

  • CHU de Tours

    Tours,
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif,
    France

    Active - Recruiting

  • CH Eure Seine - Hopital d'Evreux Vernon

    Évreux,
    France

    Site Not Available

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