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One dose may not fit all: blood tests could tailor cancer drug dosing

NCT ID NCT05443087

Knowledge-focused Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study looks at whether measuring the amount of certain targeted cancer drugs in the blood can help find the best dose for each patient. It involves adults with advanced digestive cancers like colorectal, liver, and stomach tumors who are already taking these medications. By tracking drug levels over time and linking them to outcomes, researchers hope to develop a model that predicts the optimal dose for future patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Blood sampling to measure levels of multikinase inhibitors (regorafenib, everolimus, sunitinib, cabozantinib, encorafenib-cetuximab) in the blood
What this could lead to
If successful, this could lead to personalized dosing of these cancer drugs, improving effectiveness and reducing side effects for each patient.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test whether adjusted dosing improves outcomes. The results may not apply to all patients or drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm digestive system cancer digestive system neoplasm digestive system neuroendocrine tumor, grade 1/2 gastrointestinal stromal tumor hepatocellular carcinoma neuroendocrine neoplasm pancreatic neuroendocrine tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Digestive cancer GIST Hepatocellular carcinoma Metastatic colorectal cancer Neuroendocrine tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP Pitié Salpétrière

    RECRUITING

    Paris, France

  • CH Eure Seine - Hopital d'Evreux Vernon

    NOT_YET_RECRUITING

    Évreux, France

  • CH Saint Malo - Hôpital Broussais

    RECRUITING

    St-Malo, France

  • CH d'Auxerre

    RECRUITING

    Auxerre, France

  • CH de Bayeux - Onconormandie

    WITHDRAWN

    Bayeux, France

  • CHRU de Nancy - Hôpital de Brabois Adulte

    RECRUITING

    Nancy, France

  • CHU Rouen - Hôpital Charles Nicolle

    RECRUITING

    Rouen, France

  • CHU d'Amiens Pcardie - Hopital Sud

    RECRUITING

    Amiens, France

  • CHU de Nantes - Hôtel Dieu

    RECRUITING

    Nantes, France

  • CHU de Poitiers

    NOT_YET_RECRUITING

    Poitiers, France

  • CHU de Reims - Hôpital Robert Debré

    RECRUITING

    Reims, France

  • CHU de Tours

    RECRUITING

    Tours, France

  • Centre Antoine Lacassagne

    WITHDRAWN

    Nice, France

  • Centre Eugène Marquis

    NOT_YET_RECRUITING

    Rennes, France

  • Centre Georges Francois Leclerc

    WITHDRAWN

    Dijon, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, France

  • Centre Léon Bérard

    WITHDRAWN

    Lyon, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, France

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

    NOT_YET_RECRUITING

    Lille, France

  • Gustave Roussy

    RECRUITING

    Villejuif, France

  • Hôpital Beaujon APHP

    RECRUITING

    Clichy, France

  • Hôpital Européen Marseille

    NOT_YET_RECRUITING

    Marseille, France

  • Hôpital Privé des Côtes d'Armor - SAS

    RECRUITING

    Plérin, France

  • Hôpital Saint Joseph

    RECRUITING

    Paris, France

  • ICANS

    RECRUITING

    Strasbourg, France

  • Institut Jean Godinot

    RECRUITING

    Reims, France

  • Institut Mutualiste de Montsouris

    RECRUITING

    Paris, France

  • Institut de Cancérologie de Bourgogne

    RECRUITING

    Dijon, France

  • Institut du Cancer Avignon - Institut Sainte Catherine

    WITHDRAWN

    Avignon, France

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