Clinical Development

Development pipeline

NCT ID Research Preclin Phase 1 Phase 2 Phase 3 NDA Submission MAA
Colorectal Cancer
01681472 ISO-CC-002, Pharmacockinetics and pharmacodynamics investigation of Modufolin® in Plasma, Tumor and Adjacent Mucosa in Patients with Colon Cancer. See details.
Completed
02244632 ISO-CC-005, Phase I/II Modufolin® in Combination with 5-Fluorouracil Alone or Together with Oxaliplatin or Irinotecan in Colorectal Cancer
Ongoing-Recruiting
01397305 ISO-MC-091, An extended Feasibility Phase I/II Study of Modufolin® and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer. See details.
Completed
Osteosarcoma
02383901 ISO-MTX-OB1, A Retrospective Non-intervention Study to Characterize Folate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX (FORTO)
Results available 2016
01987102 ISO-MTX-003, Phase I/II open label dose titration and tolerability in Osteosarcoma
Ongoing - Recruiting

Clinical Studies

ISOFOL IS CURRENTLY IN PHASE I/II CLINICAL STUDIES
FOR BOTH HDMTX RESCUE AND COLORECTAL CANCER

ISO-CC-002

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

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

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

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.