Informations générales (source: ClinicalTrials.gov)
Dosing of Various Multi Kinases Inhibitors Plasma Concentrations for Patients Treated for Their Advanced Digestive Cancer, With the Aim to Determine the Best Optimal Dose for Each Treatment, in the Future (TARGETMONITO)
Interventional
N/A
UNICANCER (Voir sur ClinicalTrials)
août 2022
juin 2027
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Audrey PERRET | 21/02/2024 15:58:24 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Beaujon | Mohamed BOUATTOUR, Dr | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Xavier ADHOUTE, Dr | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugène Marquis - Rennes - France | Julien EDELINE, Dr | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - Clermont-Ferrand - France | Hervé DEVAUD, Dr | Contact (sur clinicalTrials) | |||
| CHRU de Nancy - Hôpital de Brabois Adulte - Nancy - France | Anthony LOPEZ, Dr | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Hôtel Dieu - Nantes - France | Yann TOUCHEFEU, Dr | Contact (sur clinicalTrials) | |||
| CHU de Reims - Hôpital Robert Debré - Reims - France | Olivier BOUCHE, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP Pitié Salpétrière - Paris - France | Jean Baptiste BACHET, Dr | Contact (sur clinicalTrials) | |||
| Centre Antoine Lacassagne - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Georges Francois Leclerc - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - Lille - France | Aurélien CARNOT, Dr | Contact (sur clinicalTrials) | |||
| CH d'Auxerre - Auxerre - France | Anne-Laure VILLING, Dr | Contact (sur clinicalTrials) | |||
| CH de Bayeux - Onconormandie - Bayeux - France | Contact (sur clinicalTrials) | ||||
| CH Eure Seine - Hopital d'Evreux Vernon - Évreux - France | Contact (sur clinicalTrials) | ||||
| CH Saint Malo - Hôpital Broussais - Saint-Malo - France | Romain DESGRIPPES, Dr | Contact (sur clinicalTrials) | |||
| CHU d'Amiens Pcardie - Hopital Sud - Amiens - France | Contact (sur clinicalTrials) | ||||
| CHU de Poitiers - Poitiers - France | David TOUGERON, Dr | Contact (sur clinicalTrials) | |||
| CHU de Tours - Tours - France | Contact (sur clinicalTrials) | ||||
| CHU Rouen - Hôpital Charles Nicolle - Rouen - France | Frédéric DI FIORE, Dr | Contact (sur clinicalTrials) | |||
| Groupement des hôpitaux de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul - Lille - France | Sophie DOMINGUEZ, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Européen Marseille - Marseille - France | Yves RINALDI, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Privé des Côtes d'Armor - SAS - Plérin - France | Jérôme MARTIN-BABAU, Dr | Contact (sur clinicalTrials) | |||
| ICANS - Strasbourg - France | Meher BEN ABDELGHANI, Dr | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Bourgogne - Dijon - France | Contact (sur clinicalTrials) | ||||
| Institut du Cancer Avignon - Institut Sainte Catherine - Avignon - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - Reims - France | Damien BOTSEN, Dr | Contact (sur clinicalTrials) | |||
| Institut Mutualiste de Montsouris - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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 of
care) planned with:
- Regorafenib for GIST, mCRC, and HCC,
- Everolimus for gepNET,
- Sunitinib for pNET or GIST,
- Cabozantinib for HCC,
- Encorafenib - cetuximab for mCRC
3. Life expectancy of greater than 3 months - at the discretion of the investigator
4. Measurable disease according to tumor evaluation criteria as per local practice
(Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, etc.)
5. Patients must be affiliated to a Social Security System (or equivalent)
6. Patient must have signed a written informed consent form prior to any trial specific
procedures. When the patient is physically unable to give their written consent, a
trusted person of their choice, independent from the investigator or the sponsor,
can confirm in writing the patient's consent.
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 of
care) planned with:
- Regorafenib for GIST, mCRC, and HCC,
- Everolimus for gepNET,
- Sunitinib for pNET or GIST,
- Cabozantinib for HCC,
- Encorafenib - cetuximab for mCRC
3. Life expectancy of greater than 3 months - at the discretion of the investigator
4. Measurable disease according to tumor evaluation criteria as per local practice
(Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, etc.)
5. Patients must be affiliated to a Social Security System (or equivalent)
6. Patient must have signed a written informed consent form prior to any trial specific
procedures. When the patient is physically unable to give their written consent, a
trusted person of their choice, independent from the investigator or the sponsor,
can confirm in writing the patient's consent.
1. Other concomitant anticancer systemic treatment (chronic chemotherapy, antitumor
hormone therapy or immunotherapy) than the one studied
2. Unresolved toxicity higher than NCI-CTCAE v5.0 Grade 1 attributed to any prior
therapy/procedure excluding alopecia and peripheral neuropathy
3. Prior treatment with the same MKI molecule(s) planned to be given in the cohort. If
different MKI molecules (from the one(s) planned in the study) have been previously
taken, 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 cell
carcinoma of the skin
5. Any condition that may jeopardize patient participation in the study as well as non
contraception for male and female with child-bearing potential, pregnancy or breast
feeding.
6. Patient unwilling or unable to comply with the medical follow-up required by the
standard treatment taken (including PK sampling during treatment phase and vital
status collection during follow-up phase) because of psychosocial, familial, social
or geographical reasons
7. Participation in another clinical study with an investigational medicinal product
during the last 30 days prior to inclusion and during the present study (except if
patient is included in the control arm, with placebo or with a product which have a
marketed authorisation, used as per the SmPC for the given indication)
8. Patient deprived of their liberty or under protective custody or guardianship