Monitoring targeted therapy drugs in patients with advanced digestive cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on monitoring the plasma levels of various multikinase inhibitors in patients with advanced digestive cancers, including metastatic colorectal cancer, hepatocellular carcinoma, and neuroendocrine tumors. It is a multicenter, open-label interventional study that aims to determine the optimal dosage of these therapies tailored to individual patients. Blood samples will be collected at various intervals to build a pharmacokinetics model, ensuring that treatment is both effective and safe. The study will include multiple cohorts based on the specific type of cancer and treatment regimen.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU d'Amiens Pcardie - Hopital Sud
  Amiens, France Recruiting
• CH d'Auxerre
  Auxerre, France Recruiting
• Centre Jean Perrin
  Clermont-Ferrand, France Recruiting
• Hôpital Beaujon APHP
  Clichy, France Recruiting
• Institut de Cancérologie de Bourgogne
  Dijon, France Recruiting
• Centre Oscar Lambret
  Lille, France Recruiting

Study contacts

• Principal investigator: David MALKA, Dr — Gustave ROUSSY - VILLEJUIF
• Study coordinator: Michaël CHEVROT, Ph.D
• Email: m-chevrot@unicancer.fr
• Phone: +33 (0) 1 71 93 61 61

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.