| August 5, 2005 |
| October 31, 2009 |
| July 2005 |
| September 2011 (final data collection date for primary outcome measure) |
| 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 ] |
| Overall survival and safety/toxicity. |
| Complete list of historical versions of study NCT00128102 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Overall objective response, response duration, progression-free-survival dyspnea score on LCSS-Meso and Forced Vital Capacity change. |
| |
| Suberoylanilide Hydroxamic Acid Vorinostat, MK0683 Versus Placebo in Advanced Malignant Pleural Mesothelioma |
| 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. |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
|
|
- Drug: Comparator: Suberoylanilide Hydroxamic Acid (Vorinostat, MK0683)
- Drug: Comparator: Placebo
|
- Experimental: Vorinostat
- Placebo Comparator: Placebo
|
| |
| |
| Recruiting |
| 660 |
| October 2011 |
| September 2011 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
| Contact: Toll Free Number |
1-888-577-8839 |
|
|
|
| United States, Australia, Belgium, Brazil, Canada, Croatia, Egypt, Germany, India, Italy, Japan, Mexico, Netherlands, New Zealand, Portugal, Spain, Sweden, United Kingdom |
| |
| NCT00128102 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2005_010, MK0683-014 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| October 2009 |
