Suberoylanilide Hydroxamic Acid Vorinostat, MK0683 Versus Placebo in Advanced Malignant Pleural Mesothelioma - Full Text View

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:	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 (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 Information available 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

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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
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, 10065
United States, Pennsylvania
Call for Information	Recruiting
Philadelphia, Pennsylvania, United States, 19111
Call for Information	Recruiting
Philadelphia,, Pennsylvania, United States, 19104
United States, Texas
Call for Information	Recruiting
Austin, Texas, United States, 78759
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
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
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
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 & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_010, MK0683-014
Study First Received:	August 5, 2005
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00128102 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Advanced malignant pleural mesothelioma

Additional relevant MeSH terms:

Anticarcinogenic Agents
Thoracic Neoplasms
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Vorinostat
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Lung Diseases
Mesothelioma
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009