Personalized dosing of FOLFIRINOX in pancreatic cancer patients: a phase-2 pharmacokinetic, safety and feasibility trial
Phase 1
- Conditions
- Pancreatic cancerTherapeutic area: Diseases [C] - Digestive System Diseases [C06]Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-510576-21-00
- Lead Sponsor
- Catharina Ziekenhuis Stichting
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
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 Criteria
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method