TARGETed Therapy Drug MONITOring in DIGestive Oncology

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Exclusion Criteria:

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05443087
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

UNICANCER
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David MALKA, Dr
Principal Investigator Affiliation Gustave ROUSSY - VILLEJUIF
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Digestive Cancer, Metastatic Colorectal Cancer, Hepatocellular Carcinoma, GIST, Neuroendocrine Tumors
Additional Details

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.

Arms & Interventions

Arms

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

Interventions

Other: - Blood 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU d'Amiens Pcardie - Hopital Sud, Amiens, France

Status

Recruiting

Address

CHU d'Amiens Pcardie - Hopital Sud

Amiens, ,

CH d'Auxerre, Auxerre, France

Status

Recruiting

Address

CH d'Auxerre

Auxerre, ,

Site Contact

Anne-Laure VILLING, Dr

alvilling@ch-auxerre.fr

+33 (0) 1 71 93 61 61

Avignon, France

Status

Withdrawn

Address

Institut du Cancer Avignon - Institut Sainte Catherine

Avignon, ,

CH de Bayeux - Onconormandie, Bayeux, France

Status

Withdrawn

Address

CH de Bayeux - Onconormandie

Bayeux, ,

Centre Jean Perrin, Clermont-Ferrand, France

Status

Recruiting

Address

Centre Jean Perrin

Clermont-Ferrand, ,

Hôpital Beaujon APHP, Clichy, France

Status

Recruiting

Address

Hôpital Beaujon APHP

Clichy, ,

Site Contact

Mohamed BOUATTOUR, Dr

mohamed.bouattour@aphp.fr

+33 (0) 1 71 93 61 61

Centre Georges Francois Leclerc, Dijon, France

Status

Withdrawn

Address

Centre Georges Francois Leclerc

Dijon, ,

Institut de Cancérologie de Bourgogne, Dijon, France

Status

Recruiting

Address

Institut de Cancérologie de Bourgogne

Dijon, ,

Centre Oscar Lambret, Lille, France

Status

Recruiting

Address

Centre Oscar Lambret

Lille, ,

Site Contact

Aurélien CARNOT, Dr

a-carnot@o-lambret.fr

+33 (0) 1 71 93 61 61

Lille, France

Status

Not yet recruiting

Address

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

Lille, ,

Site Contact

Sophie DOMINGUEZ, Dr

dominguez.sophie@ghicl.net

+33 (0) 1 71 93 61 61

Centre Léon Bérard, Lyon, France

Status

Withdrawn

Address

Centre Léon Bérard

Lyon, ,

Hôpital Européen Marseille, Marseille, France

Status

Not yet recruiting

Address

Hôpital Européen Marseille

Marseille, ,

Nancy, France

Status

Recruiting

Address

CHRU de Nancy - Hôpital de Brabois Adulte

Nancy, ,

Site Contact

Anthony LOPEZ, Dr

a.lopez@chru-nancy.fr

+33 (0) 1 71 93 61 61

CHU de Nantes - Hôtel Dieu, Nantes, France

Status

Recruiting

Address

CHU de Nantes - Hôtel Dieu

Nantes, ,

Site Contact

Yann TOUCHEFEU, Dr

yann.touchefeu@chu-nantes.fr

+33 (0) 1 71 93 61 61

Centre Antoine Lacassagne, Nice, France

Status

Withdrawn

Address

Centre Antoine Lacassagne

Nice, ,

APHP Pitié Salpétrière, Paris, France

Status

Recruiting

Address

APHP Pitié Salpétrière

Paris, ,

Site Contact

Jean Baptiste BACHET, Dr

jean-baptiste.bachet@aphp.fr

+33 (0) 1 71 93 61 61

Hôpital Saint Joseph, Paris, France

Status

Recruiting

Address

Hôpital Saint Joseph

Paris, ,

Institut Mutualiste de Montsouris, Paris, France

Status

Recruiting

Address

Institut Mutualiste de Montsouris

Paris, ,

Hôpital Privé des Côtes d'Armor - SAS, Plérin, France

Status

Recruiting

Address

Hôpital Privé des Côtes d'Armor - SAS

Plérin, ,

Site Contact

Jérôme MARTIN-BABAU, Dr

j.martin@cario-sante.fr

+33 (0) 1 71 93 61 61

CHU de Poitiers, Poitiers, France

Status

Not yet recruiting

Address

CHU de Poitiers

Poitiers, ,

Site Contact

David TOUGERON, Dr

david.tougeron@chu-poitiers.fr

+33 (0) 1 71 93 61 61

CHU de Reims - Hôpital Robert Debré, Reims, France

Status

Recruiting

Address

CHU de Reims - Hôpital Robert Debré

Reims, ,

Site Contact

Olivier BOUCHE, Pr

obouche@chu-reims.fr

+33 (0) 1 71 93 61 61

Institut Jean Godinot, Reims, France

Status

Recruiting

Address

Institut Jean Godinot

Reims, ,

Centre Eugène Marquis, Rennes, France

Status

Not yet recruiting

Address

Centre Eugène Marquis

Rennes, ,

Site Contact

Julien EDELINE, Dr

j.edeline@rennes.unicancer.fr

+33 (0) 1 71 93 61 61

CHU Rouen - Hôpital Charles Nicolle, Rouen, France

Status

Recruiting

Address

CHU Rouen - Hôpital Charles Nicolle

Rouen, ,

Site Contact

Frédéric DI FIORE, Dr

frederic.di-fiore@chu-rouen.fr

+33 (0) 1 71 93 61 61

CH Saint Malo - Hôpital Broussais, Saint-Malo, France

Status

Recruiting

Address

CH Saint Malo - Hôpital Broussais

Saint-Malo, ,

Site Contact

Romain DESGRIPPES, Dr

r.desgrippes@ch-stmalo.fr

+33 (0) 1 71 93 61 61

ICANS, Strasbourg, France

Status

Recruiting

Address

ICANS

Strasbourg, ,

Site Contact

Meher BEN ABDELGHANI, Dr

m.ben-abdelghani@icans.eu

+33 (0) 1 71 93 61 61

CHU de Tours, Tours, France

Status

Recruiting

Address

CHU de Tours

Tours, ,

Gustave Roussy, Villejuif, France

Status

Recruiting

Address

Gustave Roussy

Villejuif, ,

Site Contact

Audrey PERRET, Dr

audrey.perret@gustaveroussy.fr

+33 (0) 1 71 93 61 61

CH Eure Seine - Hopital d'Evreux Vernon, Évreux, France

Status

Not yet recruiting

Address

CH Eure Seine - Hopital d'Evreux Vernon

Évreux, ,

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