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

Show 30 Study Locations

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
Study First Received:	August 5, 2005
Last Updated:	November 18, 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 22, 2009