Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer

Sponsor
Isofol Medical AB
Study ID
NCT02244632
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Colorectal Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modufolin (arfolitixorin) — DRUG
    IV injection every second week for 8 weeks.
  • Fluorouracil — DRUG
    IV injection every second week for 8 weeks.
  • Oxaliplatin — DRUG
    IV infusion every second week for 8 weeks.
  • Irinotecan — DRUG
    IV infusion every second week for 8 weeks.
  • Bevacizumab — DRUG
    IV infusion every second week for 8 weeks.

Study Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
Sep 2020
Primary completion
Jan 30, 2020
Completion
Jan 30, 2020

Study Design

Enrollment
105 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Modufolin / Nordic FLV
    Modufolin in combination with 5-Fluorouracil only.
  • Experimental: Modufolin / Nordic FLOX
    Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime
  • Experimental: Modufolin / Nordic FLIRI
    Modufolin in combination with 5-Fluorouracil and Irinotecan.
  • Experimental: MOFOX
    Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime
  • Experimental: MOFOX / Bevacizumab
    Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
  • Experimental: MOFIRI
    Modufolin in combination with 5-Fluorouracil and Irinotecan

Primary Outcome Measure

Frequency and severity of dose limiting toxicity (DLT) or other Adverse Events (AE) [ Time Frame: The patients will be followed during 4 cycles of treatment (8 weeks). ]