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

Status: Recruiting
Location: See all (29) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 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

• 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 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.

Locations
Other Locations
France
CHU d'Amiens Pcardie - Hopital Sud
RECRUITING
Amiens
CH d'Auxerre
RECRUITING
Auxerre
Institut du Cancer Avignon - Institut Sainte Catherine
WITHDRAWN
Avignon
CH de Bayeux - Onconormandie
WITHDRAWN
Bayeux
Centre Jean Perrin
RECRUITING
Clermont-ferrand
Hôpital Beaujon APHP
RECRUITING
Clichy
Centre Georges Francois Leclerc
WITHDRAWN
Dijon
Institut de Cancérologie de Bourgogne
RECRUITING
Dijon
CH Eure Seine - Hopital d'Evreux Vernon
NOT_YET_RECRUITING
Évreux
Centre Oscar Lambret
RECRUITING
Lille
Groupement des hôpitaux de l'Institut Catholique de Lille - Hôpital Saint Vincent de Paul
NOT_YET_RECRUITING
Lille
Centre Léon Bérard
WITHDRAWN
Lyon
Hôpital Européen Marseille
NOT_YET_RECRUITING
Marseille
CHRU de Nancy - Hôpital de Brabois Adulte
RECRUITING
Nancy
CHU de Nantes - Hôtel Dieu
RECRUITING
Nantes
Centre Antoine Lacassagne
WITHDRAWN
Nice
APHP Pitié Salpétrière
RECRUITING
Paris
Hôpital Saint Joseph
RECRUITING
Paris
Institut Mutualiste de Montsouris
RECRUITING
Paris
Hôpital Privé des Côtes d'Armor - SAS
RECRUITING
Plérin
CHU de Poitiers
NOT_YET_RECRUITING
Poitiers
CHU de Reims - Hôpital Robert Debré
RECRUITING
Reims
Institut Jean Godinot
RECRUITING
Reims
Centre Eugène Marquis
NOT_YET_RECRUITING
Rennes
CHU Rouen - Hôpital Charles Nicolle
RECRUITING
Rouen
CH Saint Malo - Hôpital Broussais
RECRUITING
St-malo
ICANS
RECRUITING
Strasbourg
CHU de Tours
RECRUITING
Tours
Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Michaël CHEVROT, Ph.D
m-chevrot@unicancer.fr
+33 (0) 1 71 93 61 61
Time Frame
Start Date: 2022-08-29
Estimated Completion Date: 2027-06
Participants
Target number of participants: 330
Treatments
Experimental: Regorafenib - mCRC, GIST, HCC
3 x 30 = 90 patients~Patients with mCRC, GIST or HCC treated with Regorafenib
Experimental: Everolimus - gepNET
60 patients~Patients with gepNET treated with Everolimus
Experimental: Sunitinib - pNET, GIST
2 x 30 = 60 patients~Patients with pNET and GIST, treated with Sunitinib
Experimental: Cabozantinib - HCC
60 patients~Patients with HCC treated with Cabozantinib
Experimental: Encorafenib - Cetuximab - mCRC
60 patients~Patients with mCRC treated with the association Encorafenib - Cetuximab
Sponsors
Leads: UNICANCER

This content was sourced from clinicaltrials.gov