Mesothelioma News

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