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

This study is currently recruiting patients.
Verified by Merck May 2006

Sponsored by:

 Merck

Information provided by:

 Merck

ClinicalTrials.gov Identifier:

 NCT00128102

Purpose

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

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

Eligibility

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00128102

Toll Free Number      1-888-577-8839 

Alabama
      Call for Information, Birmingham,  Alabama,  35294-3300,  United States; Recruiting

California
      Call for Information, San Diego,  California,  92123,  United States; Recruiting

      Call for Information, Los Angeles,  California,  90095-7313,  United States; Recruiting

Illinois
      Call for Information, Chicago,  Illinois,  60637-1460,  United States; Recruiting

Maryland
      Call for Information, Baltimore,  Maryland,  21201,  United States; Recruiting

Minnesota
      Call for Information, Minneapolis,  Minnesota,  55455,  United States; Recruiting

Nevada
      Call for Information, Las Vegas,  Nevada,  89135,  United States; Recruiting

New York
      Call for Information, New York,  New York,  10021-6007,  United States; Recruiting

Ohio
      Call for Information, Cleveland,  Ohio,  44195,  United States; Recruiting

Oregon
      Call for Information, Portland,  Oregon,  97213,  United States; Recruiting

Pennsylvania
      Call for Information, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting

      Call for Information, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting

Virginia
      Call for Information, Norfolk,  Virginia,  23502,  United States; Recruiting

Australia
      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 

France
      Laboratoires Merck Sharp & Dohme - Chibret, Paris Cedex 8,  75114,  France; Recruiting
Jean-Marie Goehrs, Dr.  (33.1) 47.54.89.90 

Germany
      Msd Sharp & Dohme Gmbh, Haar,  85540,  Germany; Recruiting
Ottfried Zierenberg, Dr.  49 89 4561 1102 

Italy
      Merck Sharp & Dohme (Italia) S.P.A., Roma,  191,  Italy; Recruiting
Gianfranco Botta, Dr.  +39 06 36 191 187 

Netherlands
      Merck Sharp & Dohme B.V., HAARLEM,  2031 BN,  Netherlands; Recruiting
Gerard Van Leijenhorst, Dr.  31 23 515 3306 

Spain
      Merck Sharp & Dohme De Espana, S.A.E., Madrid,  28027,  Spain; Recruiting
Jorge Gonzalez-Esteban, Dr.  34 91 3210726 

Sweden
      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:  May 17, 2006
Record first received:  August 5, 2005
ClinicalTrials.gov Identifier:  NCT00128102
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-05-18

Source: www.clinicaltrials.gov