Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (MK-0683-014)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00128102
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    Vorinostat 100 mg oral capsules
  • Placebo — DRUG
    Vorinostat-matching placebo oral capsules

Study Details

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.

Key Dates

Start date
Jun 30, 2005
Status verified
Oct 2020
Primary completion
Jul 15, 2011
Completion
Nov 21, 2011

Study Design

Enrollment
661 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat
    Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment will continue until disease progression or unacceptable toxicity.
  • Placebo Comparator: Placebo
    Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment will continue until disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) ]

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