Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
330 participants
INTERVENTIONAL
2022-08-29
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Regorafenib - mCRC, GIST, HCC
3 x 30 = 90 patients
Patients with mCRC, GIST or HCC treated with Regorafenib
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
Everolimus - gepNET
60 patients
Patients with gepNET treated with Everolimus
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
Sunitinib - pNET, GIST
2 x 30 = 60 patients
Patients with pNET and GIST, treated with Sunitinib
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
Cabozantinib - HCC
60 patients
Patients with HCC treated with Cabozantinib
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
Encorafenib - Cetuximab - mCRC
60 patients
Patients with mCRC treated with the association Encorafenib - Cetuximab
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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David MALKA, Dr
Role: PRINCIPAL_INVESTIGATOR
Gustave ROUSSY - VILLEJUIF
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A01724-37
Identifier Type: OTHER
Identifier Source: secondary_id
UC-GIG-2104
Identifier Type: -
Identifier Source: org_study_id
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