Articles and Resources
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

Sponsor:

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: 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)

Arms

Assigned Interventions

1: Experimental
Vorinostat
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
Placebo
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.

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, 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 ClinicalTrials.gov identifier: NCT00128102

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

Locations
United States, Colorado
Call for Information Recruiting
Denver, Colorado, United States, 80218
United States, Illinois
Call for Information Recruiting
Chicago, Illinois, United States, 60637-1460
Call for Information Recruiting
Gurnee, Illinois, United States, 60031
United States, Louisiana
Call for Information Recruiting
New Orleans, Louisiana, United States, 70121-0000
United States, Maryland
Call for Information Recruiting
Annapolis, Maryland, United States, 21401
United States, Michigan
Call for Information Recruiting
Southfield, Michigan, United States, 48075
United States, New York
Call for Information Recruiting
New York, New York, United States, 10021-6007
United States, Pennsylvania
Call for Information Recruiting
Philadelphia, Pennsylvania, United States, 19111
Call for Information Recruiting
Philadelphia, Pennsylvania, United States, 19104
Call for Information Recruiting
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
Australia
Merck Sharp & Dohme (Australia) Pty Ltd. Recruiting
South Granville, Australia, NSW 2142
Contact: David Woolner     64-9-523-6075        
Belgium
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        
Croatia
Merck Sharp & Dohme IDEA, Inc. Recruiting
Zagreb, Croatia, 10 010
Contact: Goranka Glad Scherr     385 1 66 44 336        
Egypt
Merck Sharp & Dohme Scientific Office Recruiting
Cairo, Egypt
Contact: Sherif Canaan     202-2417-2320        
Germany
Msd Sharp & Dohme Gmbh Recruiting
Haar, Germany, 85540
Contact: Thomas Lang     49-89-4561-1536        
India
MSD Pharmaceuticals Private Ltd. Recruiting
New Delhi, India, 110011
Contact: Swashraya Shah     91-124-464-7338        
Israel
Merck Sharp & Dohme Co. Ltd. Recruiting
Petah Tikva, Israel, 49192
Contact: Raanan Cohen     972-3-9274005        
Italy
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        
Netherlands
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        
Portugal
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        
Spain
Merck Sharp & Dohme De Espana, S.A.E. Recruiting
Madrid, Spain, 28027
Contact: Jorge Gonzalez-Esteban     34-91-3210-728        
Sweden
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
Merck
Investigators
Study Director: Medical Monitor Merck

More Information


No publications provided

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

NCT00128102

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:
Mesothelioma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Vorinostat
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on August 22, 2010


Source: www.ClinicalTrials.gov