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

Basic Trial Information

Phase: Phase III
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Pharmaceutical / Industry
Protocol IDs: 2005_010, NCT00128102

Trial Description

Summary

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.

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

Disclaimer

Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Trial Contact Information

Trial Lead Organizations

Merck and Company, Incorporated

Medical Monitor Study Director
Toll Free US Number Ph: 1-888-577-8839

Trial Sites and Contacts

Haar, Germany
Merck Sharp & Dohme GmbH - Germany
Ottfried Zierenberg, Dr.
Ph: 49 89 4561 1102


 
 

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