Merck KGaA announced that recruitment has been completed for the pivotal Phase 3 EXPAND clinical trial investigating the efficacy of Erbitux (cetuximab) in treating patients with advanced gastric cancer. The international study has recruited more than 870 patients since commencing enrollment in 2008.
“Erbitux has shown promising efficacy in several Phase 2 studies so there is strong rationale for larger scale investigation of the drug’s efficacy in this disease,” explained lead investigator Dr. Florian Lordick, MD, Klinikum Braunschweig, Hannover Medical School, Germany. “Gastric cancer is known to be difficult to treat, therefore patients need new treatment options that exceed the benefit of classical chemotherapy.”
EXPAND is a multi-center, open label, randomized, controlled study taking place at 185 centers in 25 countries including Latin America, Europe, Asia-Pacific and Japan. The trial will assess the efficacy of Erbitux in combination with cisplatin and capecitabine chemotherapies as a first-line treatment for patients with advanced/metastatic gastric adenocarcinoma, including gastroesophageal junction (GEJ) adenocarcinoma. The primary endpoint of the study is progression-free survival determined by an independent review.
Date: January 5, 2010
Source: Merck KGaA
Filed Under: Drug Discovery