7 completed, 1 recruiting, 1 unknown. 7 Phase 1, 6 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 5, Recruiting 1, Unknown 1 |
| Phase 2 | 6 | Completed 4, Recruiting 1, Unknown 1 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Clinical Study of Arfolitixorin in Patients With mCRC Arfolitixorin, Leucovorin - Metastatic Colorectal Cancer (mCRC) | Phase 1 / Phase 2 | Recruiting | Isofol Medical AB | 90 | 2025-04-10 | 2026-06-29 |
| Modelle 001, TS-inhibition in Colorectal Liver Metastases Comparing Arfolitixorin and Calciumfolinate Arfolitixorin - Metastatic Colorectal Cancer | Phase 1 / Phase 2 | Unknown | Vastra Gotaland Region | 30 | 2020-02-05 | 2020-08-27 |
| A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer Arfolitixorin, Leucovorin - Colo-rectal Cancer | Phase 3 | Completed | Isofol Medical AB | 490 | 2018-12-18 | 2023-10-26 |
| Study Evaluating ECG Effects, Safety, Tolerability and Pharmacokinetics of Single Doses of Modufolin (Arfolitixorin) in Healthy Volunteers Tetrahydrofolate in Healthy Male Volunteers Modufolin (arfolitixorin) - Phase I Study in Healthy Volunteers to Evaluate ECG Effect | Phase 1 | Completed | Isofol Medical AB | 33 | 2017-07-04 | 2020-09-25 |
| Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer Modufolin (arfolitixorin), Fluorouracil, Oxaliplatin - Colorectal Neoplasm | Phase 1 / Phase 2 | Completed | Isofol Medical AB | 105 | 2014-09-01 | 2020-09-09 |
| A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX Methotrexate - Osteosarcoma | Completed | Isofol Medical AB | 116 | 2014-09-01 | 2016-09-05 | |
| Investigation of [6R] 5,10-methylenetetrahydrofolate (Arfolitixorin) as Rescue Therapy for Osteosarcoma Patients Treated With HDMTX. Calcium Folinate, [6R] 5,10-methylenetetrahydrofolate (arfolitixorin) - Osteosarcoma | Phase 1 / Phase 2 | Completed | Isofol Medical AB | 18 | 2013-12-01 | 2020-09-25 |
| PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer 6R-MTHF (arfolitixorin) 200 mg/m2, Levoleucovorin 200 mg/m2, 6R-MTHF (arfolitixorin) 60 mg/m2 - Colonic Neoplasms | Phase 1 / Phase 2 | Completed | Isofol Medical AB | 32 | 2012-09-01 | 2020-09-25 |
| An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer [6R] 5,10-methylenetetrahydrofolate (arfolitixorin), Pemetrexed - Rectal Cancer | Phase 1 / Phase 2 | Completed | Isofol Medical AB | 24 | 2011-04-14 | 2020-09-09 |
Colorectal Neoplasms (5) · Digestive System Neoplasms (3) · Gastrointestinal Diseases (3) · Gastrointestinal Neoplasms (3) · Intestinal Neoplasms (3) · Colonic Neoplasms (2) · Osteosarcoma (2) · Rectal Neoplasms (2) · Digestive System Diseases (1) · Intestinal Diseases (1) · Neoplasms (1) · Neoplasms by Site (1) · Rectal Diseases (1)
5,10-methylenetetrahydrofolic acid (4) · Leucovorin (4) · Bevacizumab (1) · Fluorouracil (1) · Irinotecan (1) · Levoleucovorin (1) · Methotrexate (1) · Oxaliplatin (1) · Pemetrexed (1)
Sweden (8) · Germany (2) · Greece (2) · Hungary (2) · Norway (2) · Poland (2) · Australia (1) · Austria (1) · Canada (1) · Czechia (1) · Denmark (1) · France (1) · Japan (1) · Spain (1) · United States (1)
Bengt G Gustavsson, PhD, MD (1) · Helena Taflin, MD, PhD (1) · Josep Tabernero, Prof. (1) · Kristoffer Derwinger, MD PhD (1) · Mikael Eriksson, MD PhD (1) · Mikael Eriksson, MD PhD. (1) · Sebastian Stintzing, Prof. Dr. MD (1)
PMID 33099678, PMID 36183444, PMID 38059497
2014 (1), 2016 (1)