TARGETed Therapy Drug MONITOring in DIGestive Oncology
TARGETMONITO
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
2 other identifiers
interventional
330
1 country
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedStudy Start
First participant enrolled
August 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 30, 2025
March 1, 2025
3.9 years
June 23, 2022
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trough concentration (Ctrough)
Trough concentration (Ctrough) shows the blood concentration reached by a drug immediately before the next dose is administered, once steady state has been attained. It can also be defined as the minimal drug concentration in the patient's body. Plasmatic measures will be performed by liquid chromatography with tandem mass spectrometry after protein precipitation by acetonitrile.
From inclusion untill the end of treatment up to 4 years
Secondary Outcomes (5)
Progression-free survival
4 years
Overall survival
4 years
Objective response rate
4 years
Disease control rate
4 years
Safety: drug toxicity
Throughout study completion, up to 4 years
Study Arms (5)
Regorafenib - mCRC, GIST, HCC
EXPERIMENTAL3 x 30 = 90 patients Patients with mCRC, GIST or HCC treated with Regorafenib
Everolimus - gepNET
EXPERIMENTAL60 patients Patients with gepNET treated with Everolimus
Sunitinib - pNET, GIST
EXPERIMENTAL2 x 30 = 60 patients Patients with pNET and GIST, treated with Sunitinib
Cabozantinib - HCC
EXPERIMENTAL60 patients Patients with HCC treated with Cabozantinib
Encorafenib - Cetuximab - mCRC
EXPERIMENTAL60 patients Patients with mCRC treated with the association Encorafenib - Cetuximab
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Other concomitant anticancer systemic treatment (chronic chemotherapy, antitumor hormone therapy or immunotherapy) than the one studied
- Unresolved toxicity higher than NCI-CTCAE v5.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and peripheral neuropathy
- 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.
- 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
- 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.
- 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
- Patient deprived of their liberty or under protective custody or guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David MALKA, Dr
Gustave ROUSSY - VILLEJUIF
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2022
First Posted
July 5, 2022
Study Start
August 29, 2022
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
March 30, 2025
Record last verified: 2025-03