Phase
Condition
Stomach Cancer
Gastric Ulcers
Liver Disorders
Treatment
Blood sampling to build population pharmacokinetics model
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient aged 18 years or over
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
Life expectancy of greater than 3 months - at the discretion of the investigator
Measurable disease according to tumor evaluation criteria as per local practice (Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, etc.)
Patients must be affiliated to a Social Security System (or equivalent)
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:
Other concomitant anticancer systemic treatment (chronic chemotherapy, antitumorhormone therapy or immunotherapy) than the one studied
Unresolved toxicity higher than NCI-CTCAE v5.0 Grade 1 attributed to any priortherapy/procedure excluding alopecia and peripheral neuropathy
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.
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
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.
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
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)
Patient deprived of their liberty or under protective custody or guardianship
Study Design
Study Description
Connect with a study center
CHU d'Amiens Pcardie - Hopital Sud
Amiens,
FranceActive - Recruiting
CH d'Auxerre
Auxerre,
FranceActive - Recruiting
Institut du Cancer Avignon - Institut Sainte Catherine
Avignon,
FranceSite Not Available
CH de Bayeux - Onconormandie
Bayeux,
FranceSite Not Available
Centre Jean Perrin
Clermont-Ferrand,
FranceActive - Recruiting
Hôpital Beaujon APHP
Clichy,
FranceActive - Recruiting
Centre Georges Francois Leclerc
Dijon,
FranceSite Not Available
Institut de Cancérologie de Bourgogne
Dijon,
FranceActive - Recruiting
Centre Oscar Lambret
Lille,
FranceActive - Recruiting
Groupement des hôpitaux de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul
Lille,
FranceSite Not Available
Centre Léon Bérard
Lyon,
FranceSite Not Available
Hôpital Européen Marseille
Marseille,
FranceSite Not Available
CHRU de Nancy - Hôpital de Brabois Adulte
Nancy,
FranceActive - Recruiting
CHU de Nantes - Hôtel Dieu
Nantes,
FranceActive - Recruiting
Centre Antoine Lacassagne
Nice,
FranceSite Not Available
APHP Pitié Salpétrière
Paris,
FranceActive - Recruiting
Hôpital Saint Joseph
Paris,
FranceActive - Recruiting
Institut Mutualiste de Montsouris
Paris,
FranceActive - Recruiting
Hôpital Privé des Côtes d'Armor - SAS
Plérin,
FranceActive - Recruiting
CHU de Poitiers
Poitiers,
FranceSite Not Available
CHU de Reims - Hôpital Robert Debré
Reims,
FranceActive - Recruiting
Institut Jean Godinot
Reims,
FranceActive - Recruiting
Centre Eugène Marquis
Rennes,
FranceSite Not Available
CHU Rouen - Hôpital Charles Nicolle
Rouen,
FranceActive - Recruiting
CH Saint Malo - Hôpital Broussais
Saint-Malo,
FranceActive - Recruiting
ICANS
Strasbourg,
FranceActive - Recruiting
CHU de Tours
Tours,
FranceActive - Recruiting
Gustave Roussy
Villejuif,
FranceActive - Recruiting
CH Eure Seine - Hopital d'Evreux Vernon
Évreux,
FranceSite Not Available
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