RecruitingNot ApplicableNCT05443087

TARGETed Therapy Drug MONITOring in DIGestive Oncology

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


Sponsor

UNICANCER

Enrollment

330 participants

Start Date

Aug 29, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether monitoring blood levels of targeted cancer drugs (such as regorafenib, everolimus, sunitinib, cabozantinib, or encorafenib-cetuximab) can help doctors adjust doses to improve outcomes for patients with digestive cancers. **You may be eligible if...** - You are 18 years or older - You have advanced digestive cancer (such as colorectal cancer, liver cancer, gastrointestinal stromal tumor, or pancreatic neuroendocrine tumor) - You are about to start one of the specific targeted drugs listed in the study - You have measurable disease on scans - You have a life expectancy of more than 3 months **You may NOT be eligible if...** - You have severely impaired liver, kidney, or blood function - You are pregnant or breastfeeding - You are enrolled in another conflicting clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood sampling to build population pharmacokinetics model

Determine for each drug plasmatic exposure (Css, trough) through the PopPK model. Concentrations measured at the following time points: * 1 month after the first treatment administration * 2 months after the first treatment administration * In case of progression * In case of severe toxicities (AESI) related to the drug received


Locations(29)

CHU d'Amiens Pcardie - Hopital Sud

Amiens, France

CH d'Auxerre

Auxerre, France

Institut du Cancer Avignon - Institut Sainte Catherine

Avignon, France

CH de Bayeux - Onconormandie

Bayeux, France

Centre Jean Perrin

Clermont-Ferrand, France

Hôpital Beaujon APHP

Clichy, France

Centre Georges Francois Leclerc

Dijon, France

Institut de Cancérologie de Bourgogne

Dijon, France

CH Eure Seine - Hopital d'Evreux Vernon

Évreux, France

Centre Oscar Lambret

Lille, France

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

Lille, France

Centre Léon Bérard

Lyon, France

Hôpital Européen Marseille

Marseille, France

CHRU de Nancy - Hôpital de Brabois Adulte

Nancy, France

CHU de Nantes - Hôtel Dieu

Nantes, France

Centre Antoine Lacassagne

Nice, France

APHP Pitié Salpétrière

Paris, France

Hôpital Saint Joseph

Paris, France

Institut Mutualiste de Montsouris

Paris, France

Hôpital Privé des Côtes d'Armor - SAS

Plérin, France

CHU de Poitiers

Poitiers, France

CHU de Reims - Hôpital Robert Debré

Reims, France

Institut Jean Godinot

Reims, France

Centre Eugène Marquis

Rennes, France

CHU Rouen - Hôpital Charles Nicolle

Rouen, France

CH Saint Malo - Hôpital Broussais

St-Malo, France

ICANS

Strasbourg, France

CHU de Tours

Tours, France

Gustave Roussy

Villejuif, France

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NCT05443087


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