Clinical Development

Development pipeline

NCT ID Research Preclin Phase 1 Phase 2 Phase 3
Colorectal Cancer
01681472 ISO-CC-002, a Phase I/II Pharmacockinetics and pharmacodynamics clinical investigation of Modufolin® in Plasma, Tumor and Adjacent Mucosa in Patients with Colon Cancer. Clinical Trial Link
Completed
01397305 ISO-MC-091, Phase I/II Study where Pemetrexed is co-administered with Modufolin® to newly diagnosed, non-cytostatically-treated patients with resectable Rectal Cancer. Clinical Trial Link
Completed
02244632 ISO-CC-005, Phase I/II Modufolin® in Combination with 5-Fluorouracil Alone or with Irinotecamn or Oxaliplatin ± bevacizumab in patients with colorectal cancer.
Ongoing
Osteosarcoma
02383901 ISO-MTX-OB1, A Retrospective Non-intervention Study tto investigate how rescue treatment with folates in patients with osteosarcoma works in clinical context. Clinical Trial Link
Results available
01987102 ISO-MTX-003, Phase I/II study intended to identify the Modufolin® dose to be used in continued clinical development for in the osteosarcoma indication. Clinical Trial Link
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.