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