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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
   
   
 

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