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