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

Condition(s) targeted: Mesothelioma; Lung Cancer

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

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Overall contact:
Toll Free Number, Phone: 1-888-577-8839

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)

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

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

Primary outcome: 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.

Secondary outcome: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Toll Free Number, Phone: 1-888-577-8839

Merck Sharp & Dohme (Australia) Pty Ltd., South Granville NSW 2142, Australia; Recruiting
David Woolner, Phone: 64-9-523-6075

Merck Sharp & Dohme B.V., Bruxelles 1180, Belgium; Recruiting
Nathalie Schrameijer, Phone: 32-2-373-4310

Msd Sharp & Dohme Gmbh, Haar 85540, Germany; Recruiting
Thomas Lang, Phone: 49-89-4561-1536

Merck Sharp & Dohme (Italia) S.P.A., Roma 191, Italy; Recruiting
Gianfranco Botta, Phone: 39 06 36 191187

Merck Sharp & Dohme B.V., Haarlem 2031 BN, Netherlands; Recruiting
Caroline Doornebos, Phone: 31-23-515-3362

Merck Sharp & Dohme (New Zealand) Ltd.,, Auckland, New Zealand; Recruiting
David Woolner, Phone: 64-9523-6075

Merck Sharp & Dohme De Espana, S.A.E., Madrid 28027, Spain; Recruiting
Jorge Gonzalez-Esteban, Phone: 34-91-3210-728

Merck Sharp & Dohme (Sweden) AB, Sollentuna 192 07, Sweden; Recruiting
Roger Juhlin, Phone: 46-8-626-1 458

Merck Sharp & Dohme Ltd., Hoddesdon, Hertfordshire EN11 9BU, United Kingdom; Recruiting
Paul Robinson, Phone: 44 1992 452396

Call for Information, Pittsburgh, Pennsylvania 15232, United States; Recruiting

Merck Sharp & Dohme Farmaceutica Ltda., Sao Paulo, SP 04717-004, Brazil; Recruiting
Jose Octavio P. Costa Filo, Phone: 55-11-5189-7942

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: July 2005
Last updated: October 15, 2008