Date: 2012-07-23
Type of information: Results
phase: 3
Announcement: results
Company: Bayer Health care (Germany) Onyx Pharmaceuticals (USA) Astellas Pharma (Japan)
Product: Tarceva® (erlotinib)
Action mechanism:
Disease: unresectable hepatocellular carcinoma
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The SEARCH (Sorafenib and Erlotinib, a rAndomized tRial protoCol for the treatment of patients with Hepatocellular carcinoma) trial was an international multicenter placebo-controlled Phase 3 study that randomized 720 patients with advanced liver cancer. The study examined whether the addition of Tarceva® to Nexavar® prolongs survival as compared to Nexavar® alone in patients with unresectable HCC. The primary endpoint of the study was overall survival (OS) and the secondary endpoints were safety, time to radiographic progression (TTP), disease control rate (DCR) and patient-reported outcome. Patients were randomized to receive either 400 mg of Nexavar® twice daily and 150 mg of Tarceva® once daily or 400 mg of Nexavar® twice daily with matching placebo.
Latest
news: Bayer HealthCare Pharmaceuticals, Onyx Pharmaceuticals, and Astellas Pharma have announced that a Phase 3 trial evaluating the efficacy and safety of the addition of Tarceva® (erlotinib) tablets to Nexavar® (sorafenib) tablets did not improve overall survival for patients with unresectable hepatocellular carcinoma (HCC) vs. Nexavar alone. The SEARCH trial compared Nexavar® in combination with Tarceva® to Nexavar® alone. The safety and tolerability of the treatment combination were generally as expected based upon experience and use of the two products alone and there were no new or unexpected toxicities or changes to the respective product safety profiles observed. Data from this study will be presented at an upcoming scientific meeting.
