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

September 7, 2020 updated by: Isofol Medical AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark
        • Odense University Hospital
  • Greece
      • Athens, Greece
        • 251 General Airforce Hospital
      • Athens, Greece
        • Medical School University of Athens, Aretaieio Hospital
      • Athens, Greece
        • Metropolitan General Hospital
      • Athens, Greece
        • University Genral Hospital Attikon
      • Iráklion, Greece
        • University General Hospital of Heraklion
  • Norway
      • Oslo, Norway
        • Oslo University Hospital - Radiumhospitalet
      • Oslo, Norway
        • Oslo University Hospital - Ulleval
  • Sweden
      • Göteborg, Sweden, 461 85
        • Sahlgrenska University Hospital
      • Skövde, Sweden
        • Skaraborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Advanced metastatic colorectal (Stage IV) cancer verified by biopsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modufolin / Nordic FLV
Modufolin in combination with 5-Fluorouracil only.
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
  • 6R-MTHF
  • ISO-901
  • arfolitixorin
  • [6R] 5,10-methylenetetrahydrofolate
  • 6R-methylene THF
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
  • 5-FU
  • Adrucil
  • 5-Flourouacil
  • 5-Fluoro-1H,3H-pyrimidine-2,4-dione
Experimental: Modufolin / Nordic FLOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
  • 6R-MTHF
  • ISO-901
  • arfolitixorin
  • [6R] 5,10-methylenetetrahydrofolate
  • 6R-methylene THF
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
  • 5-FU
  • Adrucil
  • 5-Flourouacil
  • 5-Fluoro-1H,3H-pyrimidine-2,4-dione
Drug: Oxaliplatin
IV infusion every second week for 8 weeks.
Other Names:
  • Eloxatin
  • [(1R,2R)-cyclohexane-1,2-diamine](ethanedioato-O,O')platinum(II)
  • Olatin
  • Oxamed
  • Oxitropic
Experimental: Modufolin / Nordic FLIRI
Modufolin in combination with 5-Fluorouracil and Irinotecan.
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
  • 6R-MTHF
  • ISO-901
  • arfolitixorin
  • [6R] 5,10-methylenetetrahydrofolate
  • 6R-methylene THF
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
  • 5-FU
  • Adrucil
  • 5-Flourouacil
  • 5-Fluoro-1H,3H-pyrimidine-2,4-dione
Drug: Irinotecan
IV infusion every second week for 8 weeks.
Other Names:
  • Campto
  • (+)-(4S)-4,11-Dietyl-4-hydroxi-9-[(4-piperidinopiperidino)karbonyloxi]-1H-pyrano[3¢,4¢:6,7]indolizino[1,2-b]kinolin-3,14-(4H,12H)dion
  • Irinosor
  • Namedica
Experimental: MOFOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
  • 6R-MTHF
  • ISO-901
  • arfolitixorin
  • [6R] 5,10-methylenetetrahydrofolate
  • 6R-methylene THF
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
  • 5-FU
  • Adrucil
  • 5-Flourouacil
  • 5-Fluoro-1H,3H-pyrimidine-2,4-dione
Drug: Oxaliplatin
IV infusion every second week for 8 weeks.
Other Names:
  • Eloxatin
  • [(1R,2R)-cyclohexane-1,2-diamine](ethanedioato-O,O')platinum(II)
  • Olatin
  • Oxamed
  • Oxitropic
Experimental: MOFOX / Bevacizumab
Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
  • 6R-MTHF
  • ISO-901
  • arfolitixorin
  • [6R] 5,10-methylenetetrahydrofolate
  • 6R-methylene THF
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
  • 5-FU
  • Adrucil
  • 5-Flourouacil
  • 5-Fluoro-1H,3H-pyrimidine-2,4-dione
Drug: Oxaliplatin
IV infusion every second week for 8 weeks.
Other Names:
  • Eloxatin
  • [(1R,2R)-cyclohexane-1,2-diamine](ethanedioato-O,O')platinum(II)
  • Olatin
  • Oxamed
  • Oxitropic
Drug: Bevacizumab
IV infusion every second week for 8 weeks.
Other Names:
  • Avastin
Experimental: MOFIRI
Modufolin in combination with 5-Fluorouracil and Irinotecan
Drug: Modufolin (arfolitixorin)
IV injection every second week for 8 weeks.
Other Names:
  • 6R-MTHF
  • ISO-901
  • arfolitixorin
  • [6R] 5,10-methylenetetrahydrofolate
  • 6R-methylene THF
Drug: Fluorouracil
IV injection every second week for 8 weeks.
Other Names:
  • 5-FU
  • Adrucil
  • 5-Flourouacil
  • 5-Fluoro-1H,3H-pyrimidine-2,4-dione
Drug: Irinotecan
IV infusion every second week for 8 weeks.
Other Names:
  • Campto
  • (+)-(4S)-4,11-Dietyl-4-hydroxi-9-[(4-piperidinopiperidino)karbonyloxi]-1H-pyrano[3¢,4¢:6,7]indolizino[1,2-b]kinolin-3,14-(4H,12H)dion
  • Irinosor
  • Namedica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Primary safety variables will consist of monitoring and recording of DLTs and any significant AE that have led to adjustments in the therapy administration.
The patients will be followed during 4 cycles of treatment (8 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isofol Medical AB

Investigators

  • Principal Investigator: Göran Carlsson, MD, Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

January 30, 2020

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISO-CC-005
  • 2014-001862-84 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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