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

An Open-label, Multiple-site, Phase I/II Dose Cohort Trial of [6R] 5,10-Methylene Tetrahydrofolate (Modufolin®) in Combination With a Fixed Dose of 5-Fluorouracil (5-FU) Alone or Together With a Fixed Dose of Oxaliplatin or Irinotecan in Patients With Stage IV Colorectal Cancer

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02244632
Enrollment
105
Registered
2014-09-19
Start date
2014-09-30
Completion date
2020-01-30
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasm

Keywords

Colorectal cancer, Colorectal carcinoma, Colorectal tumors, Intestinal Neoplasm, Gastrointestinal Neoplasm, Gastrointestinal disease, 5,10-methylenetetrahydrofolate, Tetrahydrofolates, Therapeutic uses, Pharmacokinetics, Pharmacodynamics, Safety assessments

Brief summary

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.

Detailed description

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.

Interventions

DRUGModufolin (arfolitixorin)

IV injection every second week for 8 weeks.

DRUGFluorouracil

IV injection every second week for 8 weeks.

DRUGOxaliplatin

IV infusion every second week for 8 weeks.

DRUGIrinotecan

IV infusion every second week for 8 weeks.

DRUGBevacizumab

IV infusion every second week for 8 weeks.

Sponsors

Isofol Medical AB
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Advanced metastatic colorectal (Stage IV) cancer verified by biopsy

Design outcomes

Primary

MeasureTime frameDescription
Frequency and severity of dose limiting toxicity (DLT) or other Adverse Events (AE)The patients will be followed during 4 cycles of treatment (8 weeks).Primary safety variables will consist of monitoring and recording of DLTs and any significant AE that have led to adjustments in the therapy administration.

Countries

Denmark, Greece, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026