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Suberoylanilide Hydroxamic Acid (SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma

This study is currently recruiting patients.
Verified by Merck April 2007

Sponsored by:


Information provided by:

Merck Identifier:



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.




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

MedlinePlus related topics:  Lung Cancer;   Mesothelioma

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy.

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

Study start: July 2005


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


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

Location and Contact Information

Please refer to this study by 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

      Merck Sharp & Dohme (Australia) Pty Ltd., South Granville,  NSW 2142,  Australia; Recruiting

      David Woolner  64-9523-6075 

Canada, Quebec
      Merck Frosst Canada Ltd., Kirkland,  Quebec,  H9H 3L1,  Canada; Recruiting

      Francois Bertrand, Dr.  1-514-428-2641 

      Msd Sharp & Dohme Gmbh, Haar,  85540,  Germany; Recruiting

      Ottfried Zierenberg, Dr.  49 89 4561 1102 

      Merck Sharp & Dohme (Italia) S.P.A., Roma,  191,  Italy; Recruiting

      Gianfranco Botta, Dr.  +39 06 36 191 187 

      Merck Sharp & Dohme B.V., HAARLEM,  2031 BN,  Netherlands; Recruiting

      Gerard Van Leijenhorst, Dr.  31 23 515 3306 

      Merck Sharp & Dohme De Espana, S.A.E., Madrid,  28027,  Spain; Recruiting

      Jorge Gonzalez-Esteban, Dr.  34 91 3210726 

      Merck Sharp & Dohme (Sweden) AB, Sollentuna,  192 07,  Sweden; Recruiting

      Roger Juhlin, Dr.  46-8-626-1 458 

United Kingdom, Hertfordshire
      Merch Sharp & Dohme Ltd., Hoddesdon,  Hertfordshire,  EN11 9BU,  United Kingdom; Recruiting

      John Young, Dr.  44 1992 452341 
      Study chairs or principal investigators

      Medical Monitor,  Study Director,  Merck   

More Information

Study ID Numbers:  2005_010
Last Updated:  April 6, 2007
Record first received:  August 5, 2005 Identifier:  NCT00128102
Obsolete Identifier:   NCT00265577; NCT00290784

Health Authority: United States: Food and Drug Administration processed this record on April 12, 2007