The following clinical trial is very unusual in that it uses a placebo versus a new treatment. Placebos are rarely used in cancer trials or other trials involving life threatening diseases. This trial is listed in PDQ, the cancer information database of the National Cancer Institute (NCI). All but one of the trial locations is in Europe with the lone American site being in Pittsburgh, Pennsylvania.
Suberoylanilide Hydroxamic Acid (SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma
Basic Trial Information
Phase III, Phase II Treatment trial.
Trail is active and accepting patients.
Age: 18 and over
Pharmaceutical / Industry trial
ID numbers: 2005_010, MK0683-014, NCT00128102
Trial Description
Summary
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)
Eligibility 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 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
Trial Contact Information
Trial Lead Organizations/Sponsors
Merck and Company, Incorporated
Medical Monitor Study Director
Toll Free Number Ph: 1-888-577-8839
Trial Sites
U.S.A.
Pennsylvania
Pittsburgh
Call for Information
Germany
Haar
Merck Sharp & Dohme GmbH - Germany
Thomas Lang Ph: 49-89-4561-1536
Netherlands
Haarlem
Merck Sharp & Dohme B.V.
Gerard Van Leijenhorst Ph: 31 23 515 3306
New Zealand
Auckland
Merck Sharp and Dohme New Zealand LTD
David Woolner Ph: 64-9523-6075
Spain
Madrid
Merck Sharp and Dohme de Espana, SA
Jorge Gonzalez-Esteban Ph: 34 91 3210726
Sweden
Sollentuna
Merck Sharp & Dohme (Sweden) AB
Roger Juhlin Ph: 46-8-626-1 458
United Kingdom
Hoddesdon
Merck Sharp & Dohme Limited - United Kingdom
Paul Robinson Ph: 44 1992 452341
Link to the current ClinicalTrials.gov record. 1
NLM Identifer NCT00128102
Information obtained from ClinicalTrials.gov on March 21, 2008
Note: Information about this trial is from the ClinicalTrials.gov database.