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

(Summary Last Modified November 4, 2005)

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.

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

Official Title: Suberoylanilide Hydroxamic Acid (SAHA) Versus Placebo in Advanced Malignant Pleural Mesothelioma Refractory to Systemic Chemotherapy

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

Nevada
Call for Information, Las Vegas, Nevada, 89135, United States; Recruiting

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

Linda Swan, Dr. 612-9795-9377

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

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

France
Laboratoires Merck Sharp & Dohme - Chibret, Paris Cedex 8, 75114, France; Recruiting

Jean-Marie Goehrs, Dr. (33.1) 47.54.89.90
Italy
Merck Sharp & Dohme (Italia) S.P.A., Roma, 191, Italy; Recruiting
Gianfranco Botta, Dr. +39 06 36 191 187

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

Study chairs or principal investigators

Medical Monitor, Study Director, Merck

*** POSTED NOVEMBER 9, 2005 ***