Phase 3 Trial to Test Metastatic Colorectal Cancer Treatment
The first patient has enrolled in a phase 3 trial that will test arfolitixorin for the treatment of metastatic colorectal cancer, according the manufacturer, Isofol Medical AB.
“We are now looking forward to quickly ramp up enrollment to meet the interest from participating hospitals and physicians,” Karin Ganlöv, MD, Isofol chief medical officer, said in a press release. “Arfolitixorin, which has shown promising efficacy and good safety, is an important new treatment option for patients since few new therapeutic agents have been introduced in first line treatment of [metastatic] CRC the last decade.”
The AGENT trial is a randomized, controlled study with a blinded independent review that will evaluate tumor response in approximately 440 patients with metastatic CRC. Patients will receive arfolitixorin or leucovorin, both in combination with fluorouracil, oxaliplatin and bevacizumab (Avastin, Genentech).
The primary endpoint is overall response rate, while secondary endpoints include progression free survival and duration of response. Isofol expects top-line data from the study by 2021.
Disclosures : Ganlöv is employed by Isofol.