Bayer, Onyx begin phase 3 non-small cell lung cancer trial of Nexavar tablets

By Lisa Kerner

Erie, Pa., Feb. 16 - Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc. announced the start of a randomized, double-blind, placebo-controlled phase 3 clinical trial studying Nexavar (sorafenib) tablets administered in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with non-small cell lung cancer.

Nexavar is the first oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature, according to a company news release.

The multicenter study will compare Nexavar when co-administered with two chemotherapeutic agents - carboplatin and paclitaxel - versus carboplatin and paclitaxel alone.

About 900 patients who have not received prior systemic anticancer treatment will be enrolled. Overall survival will be the primary endpoint, with secondary endpoints of progression-free survival, tumor response and safety.

Patients will be randomized to receive 400 mg of oral Nexavar twice daily or a matching placebo, in addition to carboplatin and paclitaxel for six cycles, the release stated.

Patients will continue in a maintenance phase where Nexavar or a placebo will be administered as a single agent.

The companies said the phase 3 study will be conducted at more than 130 sites in North America, South America, Europe and the Asia Pacific region.

Additionally, the Food and Drug Administration has completed a Special Protocol Assessment for the phase 3 non-small cell lung cancer trial that will form the basis of a New Drug Application.

In 2005, Nexavar received FDA approval for the treatment of patients with advanced kidney cancer. Currently, Nexavar is in phase 3 clinical trials for the treatment of advanced liver cancer and skin cancer, having been studied in more than 20 tumor types and in more than 4,000 patients.

Located in Emeryville, Calif., Onyx is engaged in the development of novel cancer therapies that target the molecular basis of cancer.

Bayer Pharmaceuticals is part of Bayer HealthCare AG, a worldwide health care company providing products that diagnose, prevent and treat disease. The company is based in West Haven, Conn.

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