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| Sponsored by: |
Merck |
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00128102 |
Purpose
This is a Phase III a study which incorporates an initial Phase II component 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.
Revised (20-Dec-2007)
| Condition | Intervention | Phase |
|
Mesothelioma Lung Cancer |
Drug: Suberoylanilide Hydroxamic Acid (SAHA) Drug: Placebo (unspecified) |
Phase II Phase III |
| MedlinePlus related topics: | Cancer Lung Cancer Mesothelioma |
| Drug Information available for: | Suberoylanilide hydroxamic acid |
| 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 (SAHA) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy |
| Estimated Enrollment: | 660 |
| Study Start Date: | July 2005 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
vorinostat
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Drug: Suberoylanilide Hydroxamic Acid (SAHA)
vorinostat 300 mg b.i.d. capsules twice daily300 mg b.i.d. capsules twice daily Up to 24 weeks of treatment.
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2: Placebo Comparator
Placebo
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Drug: Placebo (unspecified)
Pbo capsules twice daily. Up to 24 weeks of treatment.
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Toll Free Number | 1-888-577-8839 |
| United States, Pennsylvania | |||||
| Call for Information | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15232 | |||||
| United States, Texas | |||||
| Call for Information | Recruiting | ||||
| Austin, Texas, United States, 78759 | |||||
| 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 | |||||
| Germany | |||||
| Msd Sharp & Dohme Gmbh | Recruiting | ||||
| Haar, Germany, 85540 | |||||
| Contact: Thomas Lang 49-89-4561-1536 | |||||
| Italy | |||||
| Merck Sharp & Dohme (Italia) S.P.A. | Recruiting | ||||
| Roma, Italy, 191 | |||||
| Contact: Gianfranco Botta 39 06 36 191187 | |||||
| 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 | |||||
| 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 | |||||
| Merck |
| Study Director: | Medical Monitor | Merck |
More Information
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2005_010, MK0683-014 |
| First Received: | August 5, 2005 |
| Last Updated: | November 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00128102 |
| Health Authority: | United States: Food and Drug Administration |
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