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news.Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have initiated enrolling patients in the Storm sorafenib as adjuvant treatment in the prevention of recurrence of hepatocellular carcinoma trial.
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The randomized, double-blind, placebo-controlled Phase III study is evaluating Nexavar (sorafenib) tablets as adjuvant treatment, which is treatment following surgery or local radiation, for patients with hepatocellular carcinoma (HCC), or primary liver cancer.
In addition, the FDA has completed a special protocol assessment (SPA) for the Storm trial. An SPA is a written agreement on the design and size of a clinical trial intended to form the basis for a new drug application.
The international multicenter study is expected to enroll approximately 1,100 patients and will include patients who have received surgical resection or local ablation. The study will look at whether providing oral Nexavar in the adjuvant setting delays the time to recurrence and increases overall survival.
The primary endpoint of the study is recurrence free survival. Secondary endpoints include overall survival, time to recurrence, patient-reported outcomes, plasma biomarkers, safety and tolerability.
The study is enrolling patients with all HCC histologies. Patients will be randomized to receive 400mg of Nexavar twice daily or matching placebo for up to four years. The study will be conducted at more than 200 sites in North America, South America, Europe and the Asia-Pacific region, including Japan.