Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT02244632
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2014-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C013123', 'term': '5,10-methylenetetrahydrofolic acid'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-07', 'studyFirstSubmitDate': '2014-09-17', 'studyFirstSubmitQcDate': '2014-09-17', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and severity of dose limiting toxicity (DLT) or other Adverse Events (AE)', 'timeFrame': 'The patients will be followed during 4 cycles of treatment (8 weeks).', 'description': 'Primary safety variables will consist of monitoring and recording of DLTs and any significant AE that have led to adjustments in the therapy administration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colorectal cancer', 'Colorectal carcinoma', 'Colorectal tumors', 'Intestinal Neoplasm', 'Gastrointestinal Neoplasm', 'Gastrointestinal disease', '5,10-methylenetetrahydrofolate', 'Tetrahydrofolates', 'Therapeutic uses', 'Pharmacokinetics', 'Pharmacodynamics', 'Safety assessments'], 'conditions': ['Colorectal Neoplasm']}, 'referencesModule': {'references': [{'pmid': '36183444', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33099678', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAnother purpose is to investigate 4 doses of Modufolin to identify the best dose for further assessment.', 'detailedDescription': '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.\n\nWhen 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdvanced metastatic colorectal (Stage IV) cancer verified by biopsy'}, 'identificationModule': {'nctId': 'NCT02244632', 'briefTitle': 'Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Isofol Medical AB'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ISO-CC-005'}, 'secondaryIdInfos': [{'id': '2014-001862-84', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modufolin / Nordic FLV', 'description': 'Modufolin in combination with 5-Fluorouracil only.', 'interventionNames': ['Drug: Modufolin (arfolitixorin)', 'Drug: Fluorouracil']}, {'type': 'EXPERIMENTAL', 'label': 'Modufolin / Nordic FLOX', 'description': 'Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime', 'interventionNames': ['Drug: Modufolin (arfolitixorin)', 'Drug: Fluorouracil', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Modufolin / Nordic FLIRI', 'description': 'Modufolin in combination with 5-Fluorouracil and Irinotecan.', 'interventionNames': ['Drug: Modufolin (arfolitixorin)', 'Drug: Fluorouracil', 'Drug: Irinotecan']}, {'type': 'EXPERIMENTAL', 'label': 'MOFOX', 'description': 'Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime', 'interventionNames': ['Drug: Modufolin (arfolitixorin)', 'Drug: Fluorouracil', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'MOFOX / Bevacizumab', 'description': 'Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab', 'interventionNames': ['Drug: Modufolin (arfolitixorin)', 'Drug: Fluorouracil', 'Drug: Oxaliplatin', 'Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'MOFIRI', 'description': 'Modufolin in combination with 5-Fluorouracil and Irinotecan', 'interventionNames': ['Drug: Modufolin (arfolitixorin)', 'Drug: Fluorouracil', 'Drug: Irinotecan']}], 'interventions': [{'name': 'Modufolin (arfolitixorin)', 'type': 'DRUG', 'otherNames': ['[6R] 5,10-methylenetetrahydrofolate', '6R-MTHF', '6R-methylene THF', 'ISO-901', 'arfolitixorin'], 'description': 'IV injection every second week for 8 weeks.', 'armGroupLabels': ['MOFIRI', 'MOFOX', 'MOFOX / Bevacizumab', 'Modufolin / Nordic FLIRI', 'Modufolin / Nordic FLOX', 'Modufolin / Nordic FLV']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'otherNames': ['5-FU', '5-Flourouacil', '5-Fluoro-1H,3H-pyrimidine-2,4-dione', 'Adrucil'], 'description': 'IV injection every second week for 8 weeks.', 'armGroupLabels': ['MOFIRI', 'MOFOX', 'MOFOX / Bevacizumab', 'Modufolin / Nordic FLIRI', 'Modufolin / Nordic FLOX', 'Modufolin / Nordic FLV']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Eloxatin', "[(1R,2R)-cyclohexane-1,2-diamine](ethanedioato-O,O')platinum(II)", 'Olatin', 'Oxamed', 'Oxitropic'], 'description': 'IV infusion every second week for 8 weeks.', 'armGroupLabels': ['MOFOX', 'MOFOX / Bevacizumab', 'Modufolin / Nordic FLOX']}, {'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['(+)-(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', 'Campto', 'Namedica'], 'description': 'IV infusion every second week for 8 weeks.', 'armGroupLabels': ['MOFIRI', 'Modufolin / Nordic FLIRI']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'IV infusion every second week for 8 weeks.', 'armGroupLabels': ['MOFOX / Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Athens', 'country': 'Greece', 'facility': '251 General Airforce Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Medical School University of Athens, Aretaieio Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Metropolitan General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'University Genral Hospital Attikon', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Irakleio', 'country': 'Greece', 'facility': 'University General Hospital of Heraklion', 'geoPoint': {'lat': 40.7568, 'lon': 23.0356}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital - Radiumhospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital - Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '461 85', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Skövde', 'country': 'Sweden', 'facility': 'Skaraborg hospital', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}], 'overallOfficials': [{'name': 'Göran Carlsson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isofol Medical AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}