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

Isofol Medical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Colorectal Neoplasm

Treatments: Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Irinotecan; Drug: Modufolin (arfolitixorin); Drug: Fluorouracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02244632

2014-001862-84 (EudraCT Number)

ISO-CC-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Advanced metastatic colorectal (Stage IV) cancer verified by biopsy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 6 patient groups

Modufolin / Nordic FLV

Experimental group

Description:

Modufolin in combination with 5-Fluorouracil only.

Treatment:

Drug: Fluorouracil

Drug: Modufolin (arfolitixorin)

Modufolin / Nordic FLOX

Experimental group

Description:

Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime

Treatment:

Drug: Fluorouracil

Drug: Modufolin (arfolitixorin)

Drug: Oxaliplatin

Modufolin / Nordic FLIRI

Experimental group

Description:

Modufolin in combination with 5-Fluorouracil and Irinotecan.

Treatment:

Drug: Fluorouracil

Drug: Modufolin (arfolitixorin)

Drug: Irinotecan

MOFOX

Experimental group

Description:

Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime

Treatment:

Drug: Fluorouracil

Drug: Modufolin (arfolitixorin)

Drug: Oxaliplatin

MOFOX / Bevacizumab

Experimental group

Description:

Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab

Treatment:

Drug: Fluorouracil

Drug: Modufolin (arfolitixorin)

Drug: Bevacizumab

Drug: Oxaliplatin

MOFIRI

Experimental group

Description:

Modufolin in combination with 5-Fluorouracil and Irinotecan

Treatment:

Drug: Fluorouracil

Drug: Modufolin (arfolitixorin)

Drug: Irinotecan