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

NCT02244632 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-09-09

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasm

Interventions

DRUG

Modufolin (arfolitixorin)

IV injection every second week for 8 weeks.

DRUG

Fluorouracil

IV injection every second week for 8 weeks.

DRUG

Oxaliplatin

IV infusion every second week for 8 weeks.

DRUG

Irinotecan

IV infusion every second week for 8 weeks.

DRUG

Bevacizumab

IV infusion every second week for 8 weeks.

Sponsors & Collaborators

  • Isofol Medical AB

    lead INDUSTRY

Principal Investigators

  • Göran Carlsson, MD · Sahlgrenska University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2020-01-30
Completion
2020-01-30

Countries

  • Denmark
  • Greece
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02244632 on ClinicalTrials.gov