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Vorinostat (MK0683, SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma

This study is currently recruiting participants.
Study NCT00128102.   Last updated on November 5, 2008.   Information provided by Merck

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Descriptive Information Fields
Brief Title  Vorinostat (MK0683, SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma
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
Brief Summary

This is a Phase III a study which incorporates an initial Phase II component 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.

Revised (20-Dec-2007)

Detailed Description
Study Phase Phase II, Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Overall survival and safety/toxicity after 14 consecutive day treatment followed by 7 days of rest repeated in 21 day cycles until disease progression or unacceptable toxicity. [ Time Frame: Up to 24 weeks of treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Overall objective response, response duration, progression-free-survival dyspnea score on LCSS-Meso and Forced Vital Capacity change. Treatment will continue until disease progression or unacceptable toxicity. [ Time Frame: Up to 24 weeks of treatment ] [ Designated as safety issue: No ]
Condition  Mesothelioma
Lung Cancer
Intervention  Drug: Suberoylanilide Hydroxamic Acid (SAHA)
Drug: Placebo (unspecified)
MEDLINE PMIDs
Links (MedWatch - FDA maintained medical product safety Information) This link exits the ClinicalTrials.gov site
(PhRMA Clinical Study Results Database - web-based repository for clinical study results) This link exits the ClinicalTrials.gov site
(Merck: Patient & Caregiver U.S. Product Web Site) This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  660
Start Date  July 2005
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Toll Free Number     1-888-577-8839        
Location Countries  United States,   Australia,   Belgium,   Brazil,   Germany,   Italy,   Netherlands,   New Zealand,   Spain,   Sweden,   United Kingdom
Administrative Information Fields
NCT ID  NCT00128102
Organization ID 2005_010
Secondary IDs †† MK0683-014
Study Sponsor  Merck
Collaborators ††
Investigators 
Study Director:     Medical Monitor     Merck    
Information Provided By Merck
Verification Date November 2008
First Received Date  August 5, 2005
Last Updated Date November 5, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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