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New treatment option for Digestive Cancer
Official title TARGETed Therapy Drug MONITOring in DIGestive Oncology
ClinicalTrials.gov ID: NCT05443087
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Regorafenib for GIST, mCRC, and HCC,
- Everolimus for gepNET,
- Sunitinib for pNET or GIST,
You likely can't join 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)...
- Other invasive malignancies either currently active or active in the last 3 years, except adequately treated in situ carcinoma of the cervix and...
- Any condition that may jeopardize patient participation in the study as well as non contraception for male and female with child-bearing potential...
- Patient unwilling or unable to comply with the medical follow-up required by the standard treatment taken (including PK sampling during treatment...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- Patient deprived of their liberty or under protective custody or guardianship
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Auxerre, France
- Avignon, France
- Bayeux, France
- Clermont-Ferrand, France
- Clichy, France
- Dijon, France
- Évreux, France
- Lille, France
- Lyon, France
- Marseille, France
- Nancy, France
- Nantes, France
- Nice, France
- Paris, France
- Plérin, France
- Poitiers, France
- Reims, France
- Rennes, France
- Rouen, France
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Auxerre, France; Avignon, France; Bayeux, France; Clermont-Ferrand, France; Clichy, France and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.