Mesothelioma Related Clinical Trials:
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

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In Page Navigation: - General Info - Purpose - Eligibility - Contacts & Locations - Additional Information

   

Status: Recruiting
Sponsors and Collaborators: Merck
Information provided by: Merck
Government Identifier: NCT00128102

Condition: Mesothelioma; Lung Cancer
Intervention: Drug: Suberoylanilide Hydroxamic Acid (SAHA); Drug: Placebo (unspecified)

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Purpose:


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)

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), 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 Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment:   660
Study Start Date:   July 2005
Estimated Primary Completion Date:   March 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
vorinostat
Drug: Suberoylanilide Hydroxamic Acid (SAHA)
vorinostat 300 mg b.i.d. capsules twice daily300 mg b.i.d. capsules twice daily Up to 24 weeks of treatment.
2: Placebo Comparator
Placebo
Drug: Placebo (unspecified)
Pbo capsules twice daily. Up to 24 weeks of treatment.

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Eligibility:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128102

Contacts
Contact: Toll Free Number     1-888-577-8839    
Locations
United States, Pennsylvania
Call for Information     Recruiting
      Pittsburgh, Pennsylvania, United States, 15232
Australia
Merck Sharp & Dohme (Australia) Pty Ltd.     Recruiting
      South Granville, Australia, NSW 2142
      Contact: David Woolner     64-9523-6075        
Chile
Merck Sharp & Dohme (I.A.) Corp.     Recruiting
      Santiago, Chile, 6761641
      Contact: Margarita Charlin     562-655-8850        
Germany
Msd Sharp & Dohme Gmbh     Recruiting
      Haar, Germany, 85540
      Contact: Thomas Lang     49-89-4561-1536        
Netherlands
Merck Sharp & Dohme B.V.     Recruiting
      Haarlem, Netherlands, 2031 BN
      Contact: Gerard Van Leijenhorst     31 23 515 3306        
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd.,     Recruiting
      Auckland, New Zealand
      Contact: David Woolner     64-9523-6075        
Spain
Merck Sharp & Dohme De Espana, S.A.E.     Recruiting
      Madrid, Spain, 28027
      Contact: Jorge Gonzalez-Esteban     34 91 3210726        
Sweden
Merck Sharp & Dohme (Sweden) AB     Recruiting
      Sollentuna, Sweden, 192 07
      Contact: Roger Juhlin     46-8-626-1 458        
United Kingdom, Hertfordshire
Merck Sharp & Dohme Ltd.     Recruiting
      Hoddesdon, Hertfordshire, United Kingdom, EN11 9BU
      Contact: Paul Robinson     44 1992 452341        

Sponsors and Collaborators
Merck

Investigators
Study Director:     Medical Monitor     Merck    

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Additional Information:

Responsible Party:   Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:   2005_010, MK0683-014
First Received:   August 5, 2005
Last Updated:   March 7, 2008
ClinicalTrials.gov Identifier:   NCT00128102
Health Authority:   United States: Food and Drug Administration

Keywords provided by Merck:
Advanced malignant pleural mesothelioma  

Study placed in the following topic categories:
Thoracic Neoplasms
Lung Neoplasms
Lung Diseases
Mesothelioma
Adenoma
Suberoylanilide hydroxamic acid
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Mesothelioma
Anti-Inflammatory Agents
Anticarcinogenic Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents

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