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Digestive CancerTARGETMONITONCT05443087

TARGETed Therapy Drug MONITOring in DIGestive Oncology

A study testing Blood sampling to build population pharmacokinetics model in people with Digestive Cancer and Metastatic Colorectal Cancer, run by UNICANCER at 29 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Blood sampling to build population pharmacokinetics model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
29 sitesFrance
Study dates
29 Aug 2022to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 11Show fewer
  • 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.

Who cannot join

  • 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
  • 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)
  • Patient deprived of their liberty or under protective custody or guardianship

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michaël CHEVROT, Ph.D contact

+33 (0) 1 71 93 61 61

m-chevrot@unicancer.fr

29 sites in 1 country

France29 sites, 24 recruiting

  • CHU d'Amiens Pcardie - Hopital Sud

    Amiens

    Vincent HAUTEFEUILLE

    Recruiting

  • CH d'Auxerre

    Auxerre

    Anne-Laure VILLING, Dr, alvilling@ch-auxerre.fr

    Recruiting

  • Institut du Cancer Avignon - Institut Sainte Catherine

    Avignon

    Withdrawn

  • CH de Bayeux - Onconormandie

    Bayeux

    Withdrawn

  • Centre Jean Perrin

    Clermont-Ferrand

    Hervé DEVAUD, Dr, herve.devaud@clermont.unicancer.fr

    Recruiting

  • Hôpital Beaujon APHP

    Clichy

    Mohamed BOUATTOUR, Dr, mohamed.bouattour@aphp.fr

    Recruiting

  • Centre Georges Francois Leclerc

    Dijon

    Withdrawn

  • Institut de Cancérologie de Bourgogne

    Dijon

    Véronique LORGIS

    Recruiting

  • CH Eure Seine - Hopital d'Evreux Vernon

    Évreux

    Bachar EL-SAYADI

    Not yet recruiting

  • Centre Oscar Lambret

    Lille

    Aurélien CARNOT, Dr, a-carnot@o-lambret.fr

    Recruiting

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

    Lille

    Sophie DOMINGUEZ, Dr, dominguez.sophie@ghicl.net

    Not yet recruiting

  • Centre Léon Bérard

    Lyon

    Withdrawn

  • Hôpital Européen Marseille

    Marseille

    Yves RINALDI, Dr, y.rinaldi@hopital-europeen.fr

    Not yet recruiting

  • CHRU de Nancy - Hôpital de Brabois Adulte

    Nancy

    Anthony LOPEZ, Dr, a.lopez@chru-nancy.fr

    Recruiting

  • CHU de Nantes - Hôtel Dieu

    Nantes

    Yann TOUCHEFEU, Dr, yann.touchefeu@chu-nantes.fr

    Recruiting

  • Centre Antoine Lacassagne

    Nice

    Withdrawn

  • APHP Pitié Salpétrière

    Paris

    Jean Baptiste BACHET, Dr, jean-baptiste.bachet@aphp.fr

    Recruiting

  • Hôpital Saint Joseph

    Paris

    Xavier ADHOUTE, Dr, xadhoute@hopital-saint-joseph.fr

    Recruiting

  • Institut Mutualiste de Montsouris

    Paris

    David MALKA

    Recruiting

  • Hôpital Privé des Côtes d'Armor - SAS

    Plérin

    Jérôme MARTIN-BABAU, Dr, j.martin@cario-sante.fr

    Recruiting

  • CHU de Poitiers

    Poitiers

    David TOUGERON, Dr, david.tougeron@chu-poitiers.fr

    Not yet recruiting

  • CHU de Reims - Hôpital Robert Debré

    Reims

    Olivier BOUCHE, Pr, obouche@chu-reims.fr

    Recruiting

  • Institut Jean Godinot

    Reims

    Damien BOTSEN, Dr, damien.botsen@reims.unicancer.fr

    Recruiting

  • Centre Eugène Marquis

    Rennes

    Julien EDELINE, Dr, j.edeline@rennes.unicancer.fr

    Not yet recruiting

  • CHU Rouen - Hôpital Charles Nicolle

    Rouen

    Frédéric DI FIORE, Dr, frederic.di-fiore@chu-rouen.fr

    Recruiting

  • CH Saint Malo - Hôpital Broussais

    St-Malo

    Romain DESGRIPPES, Dr, r.desgrippes@ch-stmalo.fr

    Recruiting

  • ICANS

    Strasbourg

    Meher BEN ABDELGHANI, Dr, m.ben-abdelghani@icans.eu

    Recruiting

  • CHU de Tours

    Tours

    Romain CHAUTARD

    Recruiting

  • Gustave Roussy

    Villejuif

    Audrey PERRET, Dr, audrey.perret@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
Blood sampling to build population pharmacokinetics model
Keywords
multi kinases inhibitors, therapeutic drug monitoring, pharmacokinetics, pharmacodynamics, advanced digestive cancers
Medical subject headings
Gastrointestinal Neoplasms, Colorectal Neoplasms, Carcinoma, Hepatocellular, Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampling to build population pharmacokinetics modelOther

    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
Study groups in NCT05443087
Study groupRoleWhat they receive
Regorafenib - mCRC, GIST, HCCExperimental3 x 30 = 90 patients Patients with mCRC, GIST or HCC treated with Regorafenib
Receives: Other: Blood sampling to build population pharmacokinetics model
Everolimus - gepNETExperimental60 patients Patients with gepNET treated with Everolimus
Receives: Other: Blood sampling to build population pharmacokinetics model
Sunitinib - pNET, GISTExperimental2 x 30 = 60 patients Patients with pNET and GIST, treated with Sunitinib
Receives: Other: Blood sampling to build population pharmacokinetics model
Cabozantinib - HCCExperimental60 patients Patients with HCC treated with Cabozantinib
Receives: Other: Blood sampling to build population pharmacokinetics model
Encorafenib - Cetuximab - mCRCExperimental60 patients Patients with mCRC treated with the association Encorafenib - Cetuximab
Receives: Other: Blood sampling to build population pharmacokinetics model

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From inclusion untill the end of treatment up to 4 years

Secondary outcomes (5)

  1. Progression-free survival

    Progression-free survival (PFS) is the lenght of the time between inclusion and the first event of disease progression or death whatever the cause.

    Measured: 4 years

  2. Overall survival

    Overall survival (OS) is the lenght of time between inclusion and death whatever the cause.

    Measured: 4 years

  3. Objective response rate

    Objective response rate (ORR) is the percentage of patients with a best response during treatment being either complete response (CR) or partial response (PR).

    Measured: 4 years

  4. Disease control rate

    Disease control rate (DCR) is defined as the percentage of patients with a best response during treatment being either CR, PR, or Stable Disease (SD).

    Measured: 4 years

  5. Safety: drug toxicity

    Drug toxicity occurrence related to standard treatment will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0. NCI-CTCAE is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    Only AE of Specific Interest (AESI) will be collected.

    An AESI is an AE related to treatment that is:

    • G3 or G4 according to NCI-CTCAE version 5.0, or
    • Leading to treatment modification (dose reduction or treatment interruption), or
    • Categorized as serious adverse event (SAE) by the investigator, or
    • Considered as clinically significant by the investigator.

    Measured: Throughout study completion, up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start29 Aug 2022
  3. Primary completionAug 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443087
Sponsor's protocol ID
UC-GIG-2104
Other IDs
2021-A01724-37
Acronym
TARGETMONITO
Status last verified
Jul 2026
First submitted
23 Jun 2022
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Blood sampling to build population pharmacokinetics model in people with Digestive Cancer and Metastatic Colorectal Cancer, run by UNICANCER at 29 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michaël CHEVROT, Ph.D (+33 (0) 1 71 93 61 61, m-chevrot@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trough concentration (Ctrough) (time frame: From inclusion untill the end of treatment up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05443087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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