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Suberoylanilide Hydroxamic Acid Vorinostat, MK0683 Versus Placebo in Advanced Malignant Pleural Mesothelioma
This study is currently recruiting participants.
Verified by Merck, June 2010
First Received: August 5, 2005   Last Updated: June 4, 2010   History of Changes



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: Comparator: Suberoylanilide Hydroxamic Acid (Vorinostat, MK0683)
Drug: Comparator: Placebo
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Suberoylanilide Hydroxamic Acid (Vorinostat, MK0683) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy.

Resource links provided by NLM:

MedlinePlus related topics:  Cancer Lung Cancer Mesothelioma

Drug Informationavailable for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Overall survival and safety/toxicity of Vorinostat in this population. Treatment will continue until disease progression or unacceptable toxicity. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival, Overall objective response rate, dyspnea score on LCSS-Meso scale, and Forced Vital Capacity change. Treatment will continue until disease progression or unacceptable toxicity. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 660
Study Start Date: July 2005
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)


Assigned Interventions

1: Experimental
Drug: Comparator: Suberoylanilide Hydroxamic Acid (Vorinostat, MK0683)
Vorinostat 300 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment will continue until disease progression or unacceptable toxicity.
2: Placebo Comparator
Drug: Comparator: Placebo
Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment will continue until disease progression or unacceptable toxicity.


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

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, if available, 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

Contacts and Locations

Please refer to this study by its identifier: NCT00128102

Contact: Toll Free Number 1-888-577-8839

United States, Colorado
Call for Information Recruiting
Denver, Colorado, United States, 80218
United States, Illinois
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Chicago, Illinois, United States, 60637-1460
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Gurnee, Illinois, United States, 60031
United States, Louisiana
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New Orleans, Louisiana, United States, 70121-0000
United States, Maryland
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Annapolis, Maryland, United States, 21401
United States, Michigan
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Southfield, Michigan, United States, 48075
United States, New York
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New York, New York, United States, 10021-6007
United States, Pennsylvania
Call for Information Recruiting
Philadelphia, Pennsylvania, United States, 19111
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Philadelphia, Pennsylvania, United States, 19104
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Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Call for Information Recruiting
Houston, Texas, United States, 77030
Call for Information Recruiting
Temple, Texas, United States, 76508
Merck Sharp & Dohme (Australia) Pty Ltd. Recruiting
South Granville, Australia, NSW 2142
Contact: David Woolner     64-9-523-6075        
Merck Sharp & Dohme B.V. Recruiting
Bruxelles, Belgium, 1180
Contact: Nathalie Schrameijer     32-2-373-4310        
Brazil, SP
Merck Sharp & Dohme Farmaceutica Ltda. Recruiting
Sao Paulo, SP, Brazil, 04717-004
Contact: Jose Octavio P. Costa Filo     55-11-5189-7942        
Canada, Quebec
Merck Frosst Canada Ltd. Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Michel Cimon     514-428-2605        
Merck Sharp & Dohme IDEA, Inc. Recruiting
Zagreb, Croatia, 10 010
Contact: Goranka Glad Scherr     385 1 66 44 336        
Merck Sharp & Dohme Scientific Office Recruiting
Cairo, Egypt
Contact: Sherif Canaan     202-2417-2320        
Msd Sharp & Dohme Gmbh Recruiting
Haar, Germany, 85540
Contact: Thomas Lang     49-89-4561-1536        
MSD Pharmaceuticals Private Ltd. Recruiting
New Delhi, India, 110011
Contact: Swashraya Shah     91-124-464-7338        
Merck Sharp & Dohme Co. Ltd. Recruiting
Petah Tikva, Israel, 49192
Contact: Raanan Cohen     972-3-9274005        
Merck Sharp & Dohme (Italia) S.P.A. Recruiting
Roma, Italy, 191
Contact: Gianfranco Botta     39 06 36 191187        
Japan, Chiyodaku
Merck Ltd., Japan Recruiting
Tokyo, Chiyodaku, Japan, 102-8667
Contact: Tadaaki Taniguchi     81-3-6272-1547        
Mexico, D.f.
Merck Sharp & Dohme De Mexico, S.A. De C.V. Recruiting
Mexico, D.f., Mexico, 1090
Contact: Juan Diaz     52-55-5481-9825        
Merck Sharp & Dohme B.V. Recruiting
Haarlem, Netherlands, 2031 BN
Contact: Caroline Doornebos     31-23-515-3362        
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd., Recruiting
Auckland, New Zealand
Contact: David Woolner     64-9523-6075        
Peru, Lima
Merck Sharp & Dohme, Peru S.R.L. Recruiting
Surquillo, Lima, Peru, LIMA 34
Contact: Jorge Vinces     511-411-5933        
Merck Sharp & Dohme Lda Recruiting
Paco D`arcos, Portugal, 2770-192
Contact: Lai Hung Jen     351-21-4465821        
South Africa, Gauteng
MSD (Pty) LTD South Africa Recruiting
Midrand, Gauteng, South Africa, 1685
Contact: Beverley Cowper     27 11 655-3036        
Merck Sharp & Dohme De Espana, S.A.E. Recruiting
Madrid, Spain, 28027
Contact: Jorge Gonzalez-Esteban     34-91-3210-728        
Merck Sharp & Dohme (Sweden) AB Recruiting
Sollentuna, Sweden, 192 07
Contact: Roger Juhlin     46-8-626-1 458        
Turkey, Istanbul
Merck Sharp & Dohme Ilaclari Ltd. Sti Recruiting
Istinye, Istanbul, Turkey, 34460
Contact: Meltem Telaferli     90 212 365 5354        
United Kingdom, Hertfordshire
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, Hertfordshire, United Kingdom, EN11 9BU
Contact: Paul Robinson     44 1992 452396        
Sponsors and Collaborators
Study Director: Medical Monitor Merck

More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences ) Identifier:


Obsolete Identifiers: NCT00265577, NCT00290784
Other Study ID Numbers: 2005_010, MK0683-014
Study First Received: August 5, 2005
Last Updated: June 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Advanced malignant pleural mesothelioma

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Central Nervous System Agents processed this record on August 22, 2010