SYFbff5f561e2284507b84359ef85d9097aRegistry ID: 2024-510576-21-00|RecruitingPhase 2
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Secondary identifiers
interventional
N/A
1 country
5
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.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 8, 2024
Actual (reported)Percentage of patients undergoing FOLFIRINOX treated with standard-dosed (BSA) 5-FU achieving a 5-FU target AUC range (5-FU AUC0-46h between 20 and 30 mg*h/L) within two dose cycles of 5-FU
Percentage of patients undergoing FOLFIRINOX treated with 5-FU MIPD achieving a 5-FU target AUC range (5-FU AUC0-46h between 20 and 30 mg*h/L) within two dose cycles of 5-FU
Incidence of grade ≥ 1-5 toxicity, toxicity-related hospitalization, treatment delay (> 2 days) and early treatment withdrawal in patients treated with FOLFIRINOX
Turn-around-time of 5-FU MIPD (or incidence of treatment delay due to 5-FU MIPD)
Compliance to 5-FU MIPD dosing advice by treating physicians
Pharmacokinetics of 5-FU, FUH2, Irinotecan, SN-38, SN38G and Oxaliplatin
Direct medical costs of 5-FU based treatment
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Oxaliplatine Accord 5 mg/ml concentraat voor oplossing voor infusie
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry recordFormulated product
Fluorouracil Accord 50 mg/ml, oplossing voor injectie of infusie
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Oxaliplatine Accord 5 mg/ml concentraat voor oplossing voor infusie
Named ingredient: Oxaliplatin
View registry recordFluorouracil Accord 50 mg/ml, oplossing voor injectie of infusie
Named ingredient: Fluorouracil
View registry recordIsala Klinieken Stichting
Zwolle, 8025 AB, Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, 3015 GJ, Netherlands
Catharina Ziekenhuis Stichting
Eindhoven, 5623 EJ, Netherlands
Study-coordinator
First Submitted
April 8, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas
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Amsterdam UMC Stichting
Amsterdam, 1081 HV, Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333 ZA, Netherlands