NCT05443087

TARGETed Therapy Drug MONITOring in DIGestive Oncology

Dosing of Various Multi Kinases Inhibitors Plasma Concentrations for Patients Treated for Their Advanced Digestive Cancer, With the Aim to Determine the Best Optimal Dose for Each Treatment, in the Future

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Phase IV, national, multicenter, open, multi-cohort interventional study: 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

• Digestive Cancer
• Metastatic Colorectal Cancer
• Hepatocellular Carcinoma
• GIST
• Neuroendocrine Tumors

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2022-08-29
• Primary completion: 2026-08-01
• Completion: 2027-06-01
• First posted: 2022-07-05
• Last updated: 2025-03-30

Locations

29 sites across 1 country: France