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Suberoylanilide Hydroxamic Acid (SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma

Suberoylanilide Hydroxamic Acid (SAHA) Versus Placebo in Advanced Malignant Pleural MesotheliomaThis study is currently recruiting patients.
Verified by Merck April 2007

Sponsored by: Merck Information provided by: Merck ClinicalTrials.gov Identifier: NCT00128102

Purpose

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.

Condition	Intervention	Phase
Mesothelioma Lung Cancer	Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment PD or unacceptable toxicity Drug: Placebo / Duration of Treatment PD or unacceptable toxicity	Phase III

MedlinePlus related topics: Lung Cancer; Mesothelioma

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Further study details as provided by Merck:

Primary Outcomes: Overall survival and safety/toxicity.
Secondary Outcomes: Overall objective response, response duration, progression-free-survival dyspnea score on LCSS-Meso and Forced Vital Capacity
change.

Expected Total Enrollment:
660

Study start: July 2005

Eligibility

Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study: 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

Location

and Contact

Information

Please refer to this study by ClinicalTrials.gov identifier NCT00128102

Toll Free Number

1-888-577-8839

United States, Alabama
Call for Information, Birmingham, Alabama,

35294-3300,
United States; Recruiting

United States, California
Call for Information, San Diego,
California, 92123,

United States; Recruiting

Call for Information, Los Angeles,
California,
90095-7313,
United States; Recruiting

United States, Colorado
Call for Information, Aurora, Colorado,
80010,
United States; Recruiting

United States, Georgia
Call for Information, Atlanta,
Georgia, 30322,
United States; Recruiting

United States, Illinois
Call for Information, Chicago,
Illinois,
60637-1460, United States; Recruiting

United States, Maryland
Call for Information, Bethesda,
Maryland,
20892-4264,
United States; Recruiting

Call for Information, Baltimore, Maryland,
21201,
United States; Recruiting

United States, Minnesota
Call for Information, Minneapolis,
Minnesota, 55455,
United States; Recruiting

United States, Missouri
Call for Information, Saint Louis,
Missouri,
63110-1093, United States; Recruiting

United States, New York
Call for Information, New York,
New York,
10021-6007,
United States; Recruiting

United States, Ohio
Call for Information, Cleveland, Ohio,
44195,
United States; Recruiting

United States, Oregon
Call for Information, Portland,
Oregon, 97213,
United States; Recruiting

United States, Pennsylvania
Call for Information, Philadelphia,
Pennsylvania,
19104, United States; Recruiting

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

Australia
Merck Sharp & Dohme (Australia) Pty Ltd., South Granville, NSW 2142,
Australia; Recruiting

David Woolner
64-9523-6075

Canada, Quebec
Merck Frosst Canada Ltd., Kirkland,
Quebec, H9H 3L1,
Canada; Recruiting

Francois Bertrand, Dr.
1-514-428-2641

Germany
Msd Sharp & Dohme Gmbh, Haar, 85540,

Germany; Recruiting

Ottfried Zierenberg, Dr.
49 89 4561 1102

Italy
Merck Sharp & Dohme (Italia) S.P.A., Roma, 191,
Italy; Recruiting

Gianfranco Botta, Dr.
+39 06 36 191 187
Netherlands
Merck Sharp & Dohme B.V., HAARLEM, 2031 BN,
Netherlands; Recruiting

Gerard Van Leijenhorst, Dr.
31 23 515 3306

Spain
Merck Sharp & Dohme De Espana, S.A.E., Madrid, 28027,
Spain; Recruiting

Jorge Gonzalez-Esteban, Dr.
34 91 3210726

Sweden
Merck Sharp & Dohme (Sweden) AB, Sollentuna,
192 07, Sweden; Recruiting

Roger Juhlin, Dr.
46-8-626-1 458

United Kingdom, Hertfordshire
Merch Sharp & Dohme Ltd., Hoddesdon,
Hertfordshire, EN11 9BU,
United Kingdom; Recruiting

John Young, Dr.
44 1992 452341

Study chairs or principal investigators

Medical Monitor, Study Director, Merck

More Information

Study ID Numbers:
2005_010

Last Updated:
April 6, 2007
Record first received:
August 5, 2005

ClinicalTrials.gov Identifier:
NCT00128102

Obsolete Identifier:
NCT00265577; NCT00290784

Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 12, 2007

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