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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001862-84 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modufolin / Nordic FLV | Experimental | Modufolin in combination with 5-Fluorouracil only. |
|
| Modufolin / Nordic FLOX | Experimental | Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime |
|
| Modufolin / Nordic FLIRI | Experimental | Modufolin in combination with 5-Fluorouracil and Irinotecan. |
|
| MOFOX | Experimental | Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime |
|
| MOFOX / Bevacizumab | Experimental | Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modufolin (arfolitixorin) | Drug | IV injection every second week for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of dose limiting toxicity (DLT) or other Adverse Events (AE) | 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). |
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Inclusion Criteria:
Advanced metastatic colorectal (Stage IV) cancer verified by biopsy
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| Name | Affiliation | Role |
|---|---|---|
| Göran Carlsson, MD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | Denmark | ||||
| 251 General Airforce Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36183444 | Derived | Carlsson G, Koumarianou A, Guren TK, Haux J, Katsaounis P, Kentepozidis N, Pfeiffer P, Braendengen M, Mavroudis D, Taflin H, Skintemo L, Tell R, Papadimitriou C. A phase I/II study of arfolitixorin and 5-fluorouracil in combination with oxaliplatin (plus or minus bevacizumab) or irinotecan in metastatic colorectal cancer. ESMO Open. 2022 Oct;7(5):100589. doi: 10.1016/j.esmoop.2022.100589. Epub 2022 Sep 29. | |
| 33099678 |
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| MOFIRI | Experimental | Modufolin in combination with 5-Fluorouracil and Irinotecan |
|
|
| Fluorouracil | Drug | IV injection every second week for 8 weeks. |
|
|
| Oxaliplatin | Drug | IV infusion every second week for 8 weeks. |
|
|
| Irinotecan | Drug | IV infusion every second week for 8 weeks. |
|
|
| Bevacizumab | Drug | IV infusion every second week for 8 weeks. |
|
|
| Athens |
| Greece |
| Medical School University of Athens, Aretaieio Hospital | Athens | Greece |
| Metropolitan General Hospital | Athens | Greece |
| University Genral Hospital Attikon | Athens | Greece |
| University General Hospital of Heraklion | Irakleio | Greece |
| Oslo University Hospital - Radiumhospitalet | Oslo | Norway |
| Oslo University Hospital - Ullevål | Oslo | Norway |
| Sahlgrenska University Hospital | Gothenburg | 461 85 | Sweden |
| Skaraborg hospital | Skövde | Sweden |
| Derived |
| Taflin H, Odin E, Carlsson G, Tell R, Gustavsson B, Wettergren Y. Plasma deoxyuridine as a surrogate marker for toxicity and early clinical response in patients with metastatic colorectal cancer after 5-FU-based therapy in combination with arfolitixorin. Cancer Chemother Pharmacol. 2021 Jan;87(1):31-41. doi: 10.1007/s00280-020-04173-2. Epub 2020 Oct 24. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C013123 | 5,10-methylenetetrahydrofolic acid |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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