2024-510576-21-00RecruitingPhase 2
Personalized dosing of FOLFIRINOX in pancreatic cancer patients: a phase-2 pharmacokinetic, safety and feasibility trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
PART A: To validate the population AUC0-46h range of intravenous 5-FU in patients with pancreatic cancer treated with BSA-dosed FOLFIRINOX, and to determine the percentage of these patients that achieves therapeutic exposure (AUC) range of 5-FU, defined as an AUC0-46h target range of 5-FU between 20 and 30 mg*h/L. PART B: To determine the safety, model performance and feasibility of MIPD of 5-FU in pancreatic cancer patients treated with FOLFIRINOX.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 8 Apr 2024
- Start date
- 18 Sept 2024
- Lead sponsor
- Catharina Ziekenhuis Stichting
- Diseases
- Pancreatic cancer
- EU CT number
- 2024-510576-21-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with pancreatic cancer who are about to start FOLFIRINOX treatment and agree to extra blood tests for 5-FU.
- Age
- 18 years or older
- Sex
- Women and men can join
- Disease stage
- Pancreatic cancer confirmed by tissue examination. In Part B: cancer that cannot be removed by surgery and has spread locally or to other parts of the body.
- Earlier treatment
- Patients must be scheduled to start FOLFIRINOX treatment.
- Biomarker or test result
- Patients with a DPYD gene-activity score of 0 or 0.5 cannot join.
Main reasons for not taking part
- Known substance abuse
- Psychotic disorders
- Other diseases expected to interfere with the study or the patient's safety
- DPYD gene-activity score of 0 or 0.5
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or patient’s safety
Other
- Patient with DPYD gene-activity score 0 and 0.5
Who the study is looking for
- Pathologically confirmed pancreatic cancer diagnosis (for PART B: unresectable locally advanced or metastatic setting)
- Patient scheduled to start FOLFIRINOX treatment
- Patient with age ≥ 18
- Patient is able and willing to give written IFC
- Patient is able and willing to undergo extra blood sampling for 5-FU analysis
- WHO performance status 0-2
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Recruiting |
| Catharina Ziekenhuis Stichting | Eindhoven | Netherlands | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) | Leiden | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Recruiting |
| Isala Klinieken Stichting | Zwolle | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.