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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

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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

Haarlem
Merck Sharp & Dohme B.V.
Gerard Van Leijenhorst, Dr.
Ph: 31 23 515 3306

 
 

The content of this web site is for informational purposes only, and should not be considered as medical advice. Consultation with your doctor is always recommended.