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
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.
Inclusion Criteria :
- Participant must be 18 years or older with confirmed diagnosis of malignant pleural
mesothelioma
- In countries where pemetrexed an approved mesothelioma treatment, the participant's
disease has progressed or relapsed following treatment with at least one prior
chemotherapy regimen with pemetrexed and either cisplatin or carboplatin OR In
countries where pemetrexed is not approved for mesothelioma, the participant's
disease has progressed or relapsed following treatment with at least one prior
chemotherapy regimen OR Pemetrexed is not the preferred therapy for the participant
and the participant's disease has progressed or relapsed following treatment with at
least one prior chemotherapy regimen
- Participants must have received no more than 2 prior systemic therapy regimens
- Participant has a Karnofsky performance scale status of ≥70
- Participant must have adequate bone marrow, liver, and kidney function and adequate
coagulation (per prespecified laboratory values)
Extension Phase
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Overall survival
From Day 1 of study treatment to the time of death from any cause
No
United States: Food and Drug Administration
MK-0683-014
NCT00128102
June 2005
November 2011
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