ISOFOL IS CURRENTLY IN PHASE I/II CLINICAL STUDIES
FOR BOTH HDMTX RESCUE AND COLORECTAL CANCER
ISO-CC-002 (NCT01681472) is a Phase I/II single-center, blinded, randomized, pharmacokinetic and pharmacodynamic investigation with two doses of Modufolin® 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 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-CC-005 (NCT02244632) is a Phase I/II, single center, open label study aiming to identify the safety and tolearability of a dose range of Modufolin® in combination with the routine doses of 5-FU and oxaliplatin in patients with colon cancer, stage IV. The study is being initiated at Östra Hospital, Gothenburg, Sweden. The results will be used to define the dose to be documented as efficacious in a blinded multicentre trial in patients with colon cancer, stage IV.
ISO-MTX-003 (NCT01987102) is a Phase I/II open-label, multicenter
clinical trial designed to identify the 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 Modufolin® is investigated. The study is currently ongoing.