Merck & Co. announced May 27 that it is proceeding to Phase III clinical trials for vorinostat, which is currently marketed under the name Zolinza. The drug is an oral histone deacetylase (HDAC) inhibitor, and is being tested in patients with advanced malignant pleaural mesothelioma previously treated with systemic chemotherapy. Merck is currently enrolling patients in the Phase III trial.

According to the company’s news release, available in its entirety on the Mesothelioma Applied Research Foundation web site, the trial is moving forward after a favorable review of currently available safety and efficacy data from the Phase II portion of the study. This is an international study, expected to enroll 660 patients with testing centers in the United States, Belgium, Germany, the Netherlands, New Zealand, Spain, Sweden and the United Kingdom. It will be an ongoing randomized, double-blind, placebo-controlled trial.

Information provided by Merck says the trial will examine the safety, tolerability and anti-tumor activity of oral vorinostat with best supportive care as compared to best supportive care plus placebo in patients with advanced mesothelioma who have failed or are intolerant to prior chemotherapy, icnlucing pemetrexed in combination with either cisplatin or carboplatin.

Primary endpoints of the Phase III trial include overall survival as well as characterization of the overall safety and toxicity of vorinostat in patients with advanced malignant mesothelioma.

Patients interested in more information about the trial and how to enroll should call toll-free 1-866-890-6619 (in the U.S.) and 1-888-577-8839 (outside the U.S.) or visit the Merck Cancer Trials web site.

Zolinza is currently approved in the U.S. for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recrruent disease on or following two systemic therapies.

Tags: chemotherapy, cisplatin, clinical trials, Merck & Co., meso, mesothelioma, Mesothelioma Applied Research Foundation, OMB, research, United Kingdom, vorinostat, Zolinza

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