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ARTICLE | Clinical News

IV rigosertib: Phase III discontinued

December 23, 2013 8:00 AM UTC

Onconova discontinued the open-label, international Phase III ONTRAC trial after a planned interim analysis by a DSMB showed that IV rigosertib plus gemcitabine as first-line treatment of metastatic pancreatic cancer was unlikely to meet the primary endpoint of improving OS vs. gemcitabine alone. No safety concerns were reported. The trial planned to enroll about 650 patients with previously untreated metastatic pancreatic cancer to receive twice-weekly 1,800 mg/m 2 IV rigosertib plus once-weekly gemcitabine for 3 weeks of a 4-week cycle or gemcitabine alone. Onconova said it may explore alternative trials for previously untreated metastatic pancreatic cancer upon complete analysis of the data, but declined to disclose details. ...