Verified by Merck, June 2010
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.
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Condition
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Intervention
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Phase
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Mesothelioma
Lung Cancer
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Drug: Comparator: Suberoylanilide Hydroxamic Acid (Vorinostat, MK0683)
Drug: Comparator: Placebo
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Phase III
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| Study Type: |
Interventional
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| 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. |
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) |
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1: Experimental
Vorinostat
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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.
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2: Placebo Comparator
Placebo
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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.
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Eligibility
| 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 ClinicalTrials.gov identifier: NCT00128102
| Contact: Toll Free Number |
1-888-577-8839 |
|
| Call for Information |
| Denver, Colorado, United States, 80218 |
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| Chicago, Illinois, United States, 60637-1460 |
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| Gurnee, Illinois, United States, 60031 |
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| New Orleans, Louisiana, United States, 70121-0000 |
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| Annapolis, Maryland, United States, 21401 |
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| Southfield, Michigan, United States, 48075 |
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| New York, New York, United States, 10021-6007 |
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| Philadelphia, Pennsylvania, United States, 19111 |
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| Philadelphia, Pennsylvania, United States, 19104 |
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| Pittsburgh, Pennsylvania, United States, 15232 |
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| Houston, Texas, United States, 77030 |
| Call for Information |
| Temple, Texas, United States, 76508 |
| Merck Sharp & Dohme (Australia) Pty Ltd. |
| South Granville, Australia, NSW 2142 |
| Contact: David Woolner 64-9-523-6075 |
| Merck Sharp & Dohme B.V. |
| Bruxelles, Belgium, 1180 |
| Contact: Nathalie Schrameijer 32-2-373-4310 |
| Merck Sharp & Dohme Farmaceutica Ltda. |
| Sao Paulo, SP, Brazil, 04717-004 |
| Contact: Jose Octavio P. Costa Filo 55-11-5189-7942 |
| Merck Frosst Canada Ltd. |
| Kirkland, Quebec, Canada, H9H 3L1 |
| Contact: Michel Cimon 514-428-2605 |
| Merck Sharp & Dohme IDEA, Inc. |
| Zagreb, Croatia, 10 010 |
| Contact: Goranka Glad Scherr 385 1 66 44 336 |
| Merck Sharp & Dohme Scientific Office |
| Cairo, Egypt |
| Contact: Sherif Canaan 202-2417-2320 |
| Msd Sharp & Dohme Gmbh |
| Haar, Germany, 85540 |
| Contact: Thomas Lang 49-89-4561-1536 |
| MSD Pharmaceuticals Private Ltd. |
| New Delhi, India, 110011 |
| Contact: Swashraya Shah 91-124-464-7338 |
| Merck Sharp & Dohme Co. Ltd. |
| Petah Tikva, Israel, 49192 |
| Contact: Raanan Cohen 972-3-9274005 |
| Merck Sharp & Dohme (Italia) S.P.A. |
| Roma, Italy, 191 |
| Contact: Gianfranco Botta 39 06 36 191187 |
| Merck Ltd., Japan |
| Tokyo, Chiyodaku, Japan, 102-8667 |
| Contact: Tadaaki Taniguchi 81-3-6272-1547 |
| Merck Sharp & Dohme De Mexico, S.A. De C.V. |
| Mexico, D.f., Mexico, 1090 |
| Contact: Juan Diaz 52-55-5481-9825 |
| Merck Sharp & Dohme B.V. |
| Haarlem, Netherlands, 2031 BN |
| Contact: Caroline Doornebos 31-23-515-3362 |
| Merck Sharp & Dohme (New Zealand) Ltd., |
| Auckland, New Zealand |
| Contact: David Woolner 64-9523-6075 |
| Merck Sharp & Dohme, Peru S.R.L. |
| Surquillo, Lima, Peru, LIMA 34 |
| Contact: Jorge Vinces 511-411-5933 |
| Merck Sharp & Dohme Lda |
| Paco D`arcos, Portugal, 2770-192 |
| Contact: Lai Hung Jen 351-21-4465821 |
| MSD (Pty) LTD South Africa |
| Midrand, Gauteng, South Africa, 1685 |
| Contact: Beverley Cowper 27 11 655-3036 |
| Merck Sharp & Dohme De Espana, S.A.E. |
| Madrid, Spain, 28027 |
| Contact: Jorge Gonzalez-Esteban 34-91-3210-728 |
| Merck Sharp & Dohme (Sweden) AB |
| Sollentuna, Sweden, 192 07 |
| Contact: Roger Juhlin 46-8-626-1 458 |
| Merck Sharp & Dohme Ilaclari Ltd. Sti |
| Istinye, Istanbul, Turkey, 34460 |
| Contact: Meltem Telaferli 90 212 365 5354 |
| Merck Sharp & Dohme Ltd. |
| Hoddesdon, Hertfordshire, United Kingdom, EN11 9BU |
| Contact: Paul Robinson 44 1992 452396 |
Merck
| 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
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| 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
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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
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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
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ClinicalTrials.gov processed this record on August 22, 2010
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