Clinical Trial outcomes for Mesothelioma Patients: Vorinostat vs. Placebo

Read about the outcomes for a current clinical trial being conducted to study Vorinostat in patients who have been diagnosed with mesothelioma or lung cancer. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.

Primary Outcome Measures:
Overall survival and safety/toxicity after 14 consecutive day treatment followed by 7 days of rest repeated in 21 day cycles until disease progression or unacceptable toxicity. [ Time Frame: Up to 24 weeks of treatment ]
[ Designated as safety issue: Yes ]

Secondary Outcome Measures:
Overall objective response, response duration, progression-free-survival dyspnea score on LCSS-Meso and Forced Vital Capacity change. Treatment will continue until disease progression or unacceptable toxicity. [ Time Frame: Up to 24 weeks of treatment ] [ Designated as safety issue: No ]

Recruitment Information:
Recruitment Status: Recruiting
Enrollment: 660
Study Start Date: July 2005
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Arms and Assigned Interventions
1: Experimental vorinostat: Drug: Suberoylanilide Hydroxamic Acid (SAHA) vorinostat 300 mg b.i.d. capsules twice daily300 mg b.i.d. capsules twice daily Up to 24 weeks of treatment.
2. Placebo Comparator Placebo: Drug: Placebo (unspecified) Pbo capsules twice daily. Up to 24 weeks of treatment.

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