Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (0683-014 AM5, EXT1)
|ClinicalTrials.gov Identifier: NCT00128102|
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : April 20, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma Lung Cancer||Drug: vorinostat Drug: Placebo||Phase 3|
Treatment Extension Phase: Participants in this study will be eligible to enroll in an open-label treatment extension phase if they: a) were originally randomized to the vorinostat arm and have not experienced disease progression; b) were randomized to the placebo arm and meet the "Extension Phase Inclusion Criteria for Participants in the Placebo Arm" below; or c) were originally randomized to the vorinostat arm and discontinued study therapy for reasons other than progression and the investigator believes that it is in the participant's best interest to resume vorinostat treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||662 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||November 2011|
Resource links provided by the National Library of Medicine
U.S. FDA Resources
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.
Other Name: Zolinza, MK-0683
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 Measures :
- Overall survival [ Time Frame: From Day 1 of study treatment to the time of death from any cause ]
- Number of participants with adverse events characterized as Grade 3/4 according to the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) [ Time Frame: From the day of enrollment in the study until 30 days after the last dose of study drug ]
Secondary Outcome Measures :
- Progression-free survival [ Time Frame: From Day 1 of study treatment until disease progression or death from any cause ]Progression-free survival is defined as the time from randomization to the time when the meso-modified response evaluation criteria in solid tumors (RECIST) for mesothelioma are first met for disease progression or when death from any cause occurs
- Objective response rate [ Time Frame: Tumor assessments will be performed at baseline and every 42 days from the after the first dose during the first year of treatment and every 84-90 days thereafter ]Overall objective response rate is defined as the ratio of participants with responses over the total number of patients in the analysis population. Overall objective response consists of a complete response (CR) or partial response (PR) based on the meso-modified response evaluation criteria in solid tumors (RECIST) for mesothelioma occurring anytime during the study
- Percent change from baseline in dyspnea score of the Lung Cancer Symptom Scale modified for mesothelioma (LCSS-Meso) [ Time Frame: Baseline and Week 12 ]
- Percent change from baseline in forced vital capacity (FVC) [ Time Frame: Baseline and Week 12 ]
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