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

Phase 1

Completed

• Conditions: Colorectal Neoplasm
• Interventions: Drug: Modufolin (arfolitixorin); Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Irinotecan; Drug: Bevacizumab

• Registration Number: NCT02244632
• Lead Sponsor: Isofol Medical AB

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Advanced metastatic colorectal (Stage IV) cancer verified by biopsy

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modufolin / Nordic FLIRI	Modufolin (arfolitixorin)	Modufolin in combination with 5-Fluorouracil and Irinotecan.
Modufolin / Nordic FLOX	Modufolin (arfolitixorin)	Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime
MOFOX / Bevacizumab	Modufolin (arfolitixorin)	Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
MOFOX / Bevacizumab	Fluorouracil	Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
Modufolin / Nordic FLV	Modufolin (arfolitixorin)	Modufolin in combination with 5-Fluorouracil only.
MOFOX / Bevacizumab	Oxaliplatin	Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
MOFOX / Bevacizumab	Bevacizumab	Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
Modufolin / Nordic FLOX	Fluorouracil	Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime
MOFOX	Modufolin (arfolitixorin)	Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime
MOFIRI	Modufolin (arfolitixorin)	Modufolin in combination with 5-Fluorouracil and Irinotecan
MOFIRI	Fluorouracil	Modufolin in combination with 5-Fluorouracil and Irinotecan
Modufolin / Nordic FLV	Fluorouracil	Modufolin in combination with 5-Fluorouracil only.
Modufolin / Nordic FLOX	Oxaliplatin	Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime
Modufolin / Nordic FLIRI	Fluorouracil	Modufolin in combination with 5-Fluorouracil and Irinotecan.
Modufolin / Nordic FLIRI	Irinotecan	Modufolin in combination with 5-Fluorouracil and Irinotecan.
MOFOX	Fluorouracil	Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime
MOFOX	Oxaliplatin	Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime
MOFIRI	Irinotecan	Modufolin in combination with 5-Fluorouracil and Irinotecan

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (10)

251 General Airforce Hospital; 🇬🇷 Athens, Greece

Metropolitan General Hospital; 🇬🇷 Athens, Greece

Oslo University Hospital - Radiumhospitalet; 🇳🇴 Oslo, Norway

Oslo University Hospital - Ullevål; 🇳🇴 Oslo, Norway

Odense University Hospital; 🇩🇰 Odense, Denmark

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

Medical School University of Athens, Aretaieio Hospital; 🇬🇷 Athens, Greece

University Genral Hospital Attikon; 🇬🇷 Athens, Greece

University General Hospital of Heraklion; 🇬🇷 Iráklion, Greece

Skaraborg hospital; 🇸🇪 Skövde, Sweden