At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years with confirmed malignant pleural mesothelioma diagnosis
- ✓Disease progression or relapse after at least one prior chemotherapy regimen (pemetrexed-based in countries where approved, or any regimen where pemetrexed not preferred)
- ✓No more than 2 prior systemic therapy regimens
- ✓Karnofsky performance status ≥70
- ✕Active infection requiring intravenous antibiotic, antiviral, or antifungal therapy within 2 weeks of study start
- ✕Currently active second malignancy (unless disease-free >5 years from prior malignancies)
- ✕Uncontrolled brain metastases
- ✕Known HIV infection or HIV-related malignancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy
In Brief
A Phase 3 clinical trial evaluating Vorinostat and Placebo for Mesothelioma and Lung Cancer. Completed, enrolled 661 participants.
Detailed Summary
The goal of this study is to assess the efficacy and safety of an oral investigational drug suberoylanilide hydroxamic acid (vorinostat, MK-0683) compared to placebo, in the treatment of participants with advanced malignant pleural mesothelioma who have failed at least one prior chemotherapy regimen. The primary hypotheses are the following: (1) vorinostat improves overall survival (OS) compared to placebo (2) vorinostat is generally safe and well tolerated.
Study Details
Timeline
Interventions
Vorinostat 100 mg oral capsules
Vorinostat-matching placebo oral capsules