Clinical studies in phase I and II with arfolitixorin for colorectal cancer and as rescue therapy in osteosarcoma.
ISO-CC-002 (NCT01681472) is a Phase I/II single-center, blinded, randomized, pharmacokinetic and pharmacodynamic investigation with two doses of arfolitixorin compared to levoleucovorin in tumor tissue, adjacent mucosa and plasma for patients with colon cancer admitted for resection of the colon. The study is completed.
ISO-MC-091 (NCT01397305) is a Phase I/II single-center, open-label, feasibility extended study of pemetrexed single agent with arfolitixorin (Modufolin®) given to chemo-naïve patients with newly diagnosed operable rectal cancer. The study is currently ongoing but approaching completion and the last patient is undergoing treatment.
ISO-MTX-003 (NCT01987102) is a Phase I/II open-label, multicenter clinical trial designed to identify the arfolitixorin (Modufolin®) dose with most favorable safety prospect and confirmed ability to mitigate HDMTX induced toxicity during treatment of osteosarcoma patients. This is the first study in which HDMTX rescue with arfolitixorin (Modufolin®) is investigated. The study is completed.