The purpose is to characterise the tolerability of Modufolin (arfolitixorin) in combination with 5-FU alone, in combination with 5-FU and Oxaliplatin, in combination with 5-FU and Irinotecan and in combination with 5-FU, Oxaliplatin and Bevacizumab. Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further assessment.
The study will investigate the tolerability of Modufolin at four (4) different dose levels (30 to 240 mg/m2) in therapy combinations with the chemotherapeutic agents 5-FU, Oxaliplatin +/- bevcizumab, and Irinotecan. When the selected phase 2 dose is determined, 40 additional patients, will be included in the study in order to acquire more data on the safety and tolerability of Modufolin at this dose level. Twenty (20) of these additional patients will be treated in with Oxaliplatin, 20 with Irinotecan.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
IV injection every second week for 8 weeks.
IV injection every second week for 8 weeks.
IV infusion every second week for 8 weeks.
Odense University Hospital
Odense, Denmark
251 General Airforce Hospital
Athens, Greece
Medical School University of Athens, Aretaieio Hospital
Athens, Greece
Metropolitan General Hospital
Athens, Greece
Frequency and severity of dose limiting toxicity (DLT) or other Adverse Events (AE)
Primary safety variables will consist of monitoring and recording of DLTs and any significant AE that have led to adjustments in the therapy administration.
Time frame: The patients will be followed during 4 cycles of treatment (8 weeks).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IV infusion every second week for 8 weeks.
IV infusion every second week for 8 weeks.
University Genral Hospital Attikon
Athens, Greece
University General Hospital of Heraklion
Irakleio, Greece
Oslo University Hospital - Radiumhospitalet
Oslo, Norway
Oslo University Hospital - Ullevål
Oslo, Norway
Sahlgrenska University Hospital
Gothenburg, Sweden
Skaraborg hospital
Skövde, Sweden