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

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.

Timeline

Start

2005-06-30

Primary completion

2011-07-15

Completion

2011-11-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Vorinostat vs Placebo; p = 0.858; Hazard Ratio (HR) 0.98 (95% CI 0.83 to 1.17); Log Rank NCT00128102 ↗

paper INTERPRETATION: In this randomised trial, vorinostat given as a second-line or third-line therapy did not improve overall survival PMID 25800891 ↗

release “patients with advanced malignant pleural mesothelioma who previously have been treated with systemic chemotherapy containing pemetrexed did not meet its primary endpoint” merck.com ↗

Publications

• Results Krug LM, Kindler HL, Calvert H, Manegold C, Tsao AS, Fennell D, Ohman R, Plummer R, Eberhardt WE, Fukuoka K, Gaafar RM, Lafitte JJ, Hillerdal G, Chu Q, Buikhuisen WA, Lubiniecki GM, Sun X, Smith M, Baas P. Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Oncol. 2015 Apr;16(4):447-56. doi: 10.1016/S1470-2045(15)70056-2. Epub 2015 Mar 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vorinostat	Small molecule	300 mg	Oral

Indications