Suberoylanilide Hydroxamic Acid Vorinostat, MK0683 Versus Placebo in Advanced Malignant Pleural Mesothelioma - Tabular View

Tracking Information

First Received Date ^ICMJE

August 5, 2005

Last Updated Date

November 18, 2009

Start Date ^ICMJE

July 2005

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Overall survival and safety/toxicity.

Change History

Complete list of historical versions of study NCT00128102 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Overall objective response, response duration, progression-free-survival dyspnea score on LCSS-Meso and Forced Vital Capacity change.

Descriptive Information

Brief Title ^ICMJE

Suberoylanilide Hydroxamic Acid Vorinostat, MK0683 Versus Placebo in Advanced Malignant Pleural Mesothelioma

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Mesothelioma
Lung Cancer

Intervention ^ICMJE

Drug: Comparator: Suberoylanilide Hydroxamic Acid (Vorinostat, MK0683)
Drug: Comparator: Placebo

Study Arms / Comparison Groups

Experimental: Vorinostat
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

660

Estimated Completion Date

September 2011

Estimated Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Toll Free Number

1-888-577-8839

Location Countries ^ICMJE

United States, Australia, Belgium, Brazil, Canada, Croatia, Egypt, Germany, India, Israel, Italy, Japan, Netherlands, New Zealand, Portugal, South Africa, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00128102

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2005_010

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP