Bayer and Onyx Begin Enrollment in Storm Trial Studying Nexavar as Adjuvant Therapy for Patients with Liver Cancer
News Aug 26, 2008
Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. announced the companies have begun enrolling patients in the STORM Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma trial.
The randomized, double-blind, placebo-controlled Phase 3 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.
"Nexavar is the only systemic therapy with proven efficacy and tolerability in HCC across multiple patient populations," said Dimitris Voliotis, MD, vice president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals.
"Liver cancer is the third largest global cancer killer worldwide and there is a significant need for new therapies that can be used at all stages in the course of the disease to delay disease progression and prolong life," Voliotis said.
In addition, the U.S. Food and Drug Administration (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.
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