This is a study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug, suberoylanilide hydroxamic acid, in the treatment of advanced malignant pleural mesothelioma.

Condition	Intervention	Phase
Mesothelioma Lung Cancer	Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment PD or unacceptable toxicity  Drug: Placebo / Duration of Treatment PD or unacceptable toxicity	Phase III

Further study details as provided by Merck:

Primary Outcomes: Overall survival and safety/toxicity.
Secondary Outcomes: Overall objective response, response duration, progression-free-survival dyspnea score on LCSS-Meso and Forced Vital Capacity change.
Expected Total Enrollment:  660

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00128102

Toll Free Number      1-888-577-8839 

United States, Alabama
      Call for Information, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
United States, California
      Call for Information, San Diego,  California,  92123,  United States; Recruiting
      Call for Information, Los Angeles,  California,  90095-7313,  United States; Recruiting
United States, Colorado
      Call for Information, Aurora,  Colorado,  80010,  United States; Recruiting
United States, Georgia
      Call for Information, Atlanta,  Georgia,  30322,  United States; Recruiting
United States, Illinois
      Call for Information, Chicago,  Illinois,  60637-1460,  United States; Recruiting
United States, Maryland
      Call for Information, Bethesda,  Maryland,  20892-4264,  United States; Recruiting
      Call for Information, Baltimore,  Maryland,  21201,  United States; Recruiting
United States, Minnesota
      Call for Information, Minneapolis,  Minnesota,  55455,  United States; Recruiting
United States, Missouri
      Call for Information, Saint Louis,  Missouri,  63110-1093,  United States; Recruiting
United States, New York
      Call for Information, New York,  New York,  10021-6007,  United States; Recruiting
United States, Ohio
      Call for Information, Cleveland,  Ohio,  44195,  United States; Recruiting
United States, Oregon
      Call for Information, Portland,  Oregon,  97213,  United States; Recruiting
United States, Pennsylvania
      Call for Information, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
      Call for Information, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting
Australia
      Merck Sharp & Dohme (Australia) Pty Ltd., South Granville,  NSW 2142,  Australia; Recruiting
Canada, Quebec
      Merck Frosst Canada Ltd., Kirkland,  Quebec,  H9H 3L1,  Canada; Recruiting
Germany
      Msd Sharp & Dohme Gmbh, Haar,  85540,  Germany; Recruiting
Italy
      Merck Sharp & Dohme (Italia) S.P.A., Roma,  191,  Italy; Recruiting
Netherlands
      Merck Sharp & Dohme B.V., HAARLEM,  2031 BN,  Netherlands; Recruiting
Spain
      Merck Sharp & Dohme De Espana, S.A.E., Madrid,  28027,  Spain; Recruiting
Sweden
      Merck Sharp & Dohme (Sweden) AB, Sollentuna,  192 07,  Sweden; Recruiting
United Kingdom, Hertfordshire
      Merch Sharp & Dohme Ltd., Hoddesdon,  Hertfordshire,  EN11 9BU,  United Kingdom; Recruiting

Study chairs or principal investigators

Medical Monitor,  Study Director,  Merck   

Study ID Numbers:  2005_010
Last Updated:  April 6, 2007
Record first received:  August 5, 2005
ClinicalTrials.gov Identifier:  NCT00128102
Obsolete Identifier:   NCT00265577; NCT00290784
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on April 12, 2007