Suberoylanilide Hydroxamic Acid Vorinostat, MK0683 Versus Placebo in Advanced Malignant Pleural Mesothelioma

August 5, 2005

Primary Outcome Measures:

  • Overall survival and safety/toxicity of Vorinostat in this population. Treatment will continue until disease progression or unacceptable toxicity. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

  • Progression-free survival, Overall objective response rate, dyspnea score on LCSS-Meso scale, and Forced Vital Capacity change. Treatment will continue until disease progression or unacceptable toxicity. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Criteria

Inclusion Criteria
  • Patient must be 18 years or older with confirmed diagnosis of malignant pleural mesothelioma
  • Patient must have failed prior chemotherapy that included pemetrexed, if available, with either cisplatin or carboplatin
  • Patient must have adequate bone marrow, liver and kidney function
  • Patient must be capable of self-care and out of bed for more than 50% of waking hours
  • Patient must have ability to swallow pills
Exclusion Criteria
  • Patient has been treated with other investigational agent that has similar properties
  • Patient has an active infection within 2 weeks of the start of study drug, or had treatment with intravenous antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drug
  • Patient is pregnant or breast feeding
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