Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals Inc have begun an international, multi-center Phase III trial to further evaluate the safety and efficacy of the investigational drug BAY 43-9006, a novel signal transduction inhibitor, in the treatment of advanced renal cell carcinoma (kidney cancer).

"We are optimistic that BAY 43-9006 may provide a needed therapeutic option for people with renal cell carcinoma, the most common form of kidney cancer," said Ronald Bukowski, the Phase III study's lead investigator and director, Cleveland Clinic Cancer Center, Cleveland, USA. "There are currently few options for treating renal cell carcinoma once it has spread beyond the kidneys. Surgery is often not recommended for these patients, and existing treatments are limited in their effectiveness and can be highly toxic."

The primary objective of the randomized study is to confirm the activity of BAY 43-9006 in renal cell carcinoma (RCC) in a large Phase III clinical trial, with improvement in survival as the primary endpoint. The study also will assess time-to-disease progression, overall response rate, safety, quality of life and the pharmacokinetics of BAY 43-9006.

More than 800 people will participate in the Phase lll study at sites worldwide. To be eligible for the study, individuals with unresectable and/or metastatic disease must have failed a previous systemic therapy.

Bayer and Onyx also reported that the U.S. Food and Drug Administration (FDA) has recently completed and agreed upon a Special Protocol Assessment (SPA) for the pivotal Phase III trial. An SPA is a written agreement on the design and size of clinical trials intended to form the basis of a new drug application.