Personalized dosing of FOLFIRINOX in pancreatic cancer patients: a phase-2 pharmacokinetic, safety and feasibility trial
Key facts
- Where
- Amsterdam, Eindhoven, Leiden, Rotterdam és Zwolle, HollandiaSee the 5 sites
- Phase
- 2. fázis
Where in Hollandia
- Amsterdam UMC StichtingAmsterdam, HollandiaTaking people
- Catharina Ziekenhuis StichtingEindhoven, HollandiaTaking people
- Leids Universitair Medisch Centrum (LUMC)Leiden, HollandiaTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
- Isala Klinieken StichtingZwolle, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Catharina Ziekenhuis Stichting
- Trial code
- EU 2024-510576-21-00
- Record updated
- 2024. július 9.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Patient with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or patient’s safety; Patient with DPYD gene-activity score 0 and 0.5.