Vorinostat (MK0683, SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma - Tabular View

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Vorinostat (MK0683, SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma

This study is currently recruiting participants.

Study NCT00128102. Last updated on November 5, 2008. Information provided by Merck

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Vorinostat (MK0683, SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma

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

Brief 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)

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Overall survival and safety/toxicity after 14 consecutive day treatment followed by 7 days of rest repeated in 21 day cycles until disease progression or unacceptable toxicity. [ Time Frame: Up to 24 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Overall objective response, response duration, progression-free-survival dyspnea score on LCSS-Meso and Forced Vital Capacity change. Treatment will continue until disease progression or unacceptable toxicity. [ Time Frame: Up to 24 weeks of treatment ] [ Designated as safety issue: No ]

Condition ^†

Mesothelioma
Lung Cancer

Intervention ^†

Drug: Suberoylanilide Hydroxamic Acid (SAHA)
Drug: Placebo (unspecified)

MEDLINE PMIDs

Links

(MedWatch - FDA maintained medical product safety Information) This link exits the ClinicalTrials.gov site

(PhRMA Clinical Study Results Database - web-based repository for clinical study results) This link exits the ClinicalTrials.gov site

(Merck: Patient & Caregiver U.S. Product Web Site) This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

660

Start Date ^†

July 2005

Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Toll Free Number

1-888-577-8839

Location Countries ^†

United States, Australia, Belgium, Brazil, Germany, Italy, Netherlands, New Zealand, Spain, Sweden, United Kingdom

Administrative Information Fields

NCT ID ^†

NCT00128102

Organization ID

2005_010

Secondary IDs ^††

MK0683-014

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2008

First Received Date ^†

August 5, 2005

Last Updated Date

November 5, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.