TARGETed Therapy Drug MONITOring in DIGestive Oncology

Sponsor
UNICANCER
Study ID
NCT05443087
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood sampling to build population pharmacokinetics model — OTHER
    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 Details

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.

Key Dates

First listed
Jul 5, 2022
Start date
Aug 29, 2022
Status verified
Mar 2025
Primary completion
Aug 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
330 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regorafenib - mCRC, GIST, HCC
    3 x 30 = 90 patients Patients with mCRC, GIST or HCC treated with Regorafenib
  • Experimental: Everolimus - gepNET
    60 patients Patients with gepNET treated with Everolimus
  • Experimental: Sunitinib - pNET, GIST
    2 x 30 = 60 patients Patients with pNET and GIST, treated with Sunitinib
  • Experimental: Cabozantinib - HCC
    60 patients Patients with HCC treated with Cabozantinib
  • Experimental: Encorafenib - Cetuximab - mCRC
    60 patients Patients with mCRC treated with the association Encorafenib - Cetuximab

Primary Outcome Measure

Trough concentration (Ctrough) [ Time Frame: From inclusion untill the end of treatment up to 4 years ]

Central Contacts

Find similar trials

Nationwide
Liver cancer trialsNeuroendocrine tumors trialsOncology trialsGI oncology trialsHepatology trials

Related Studies