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defactinib · COMMAND

Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma

Ensayo de Verastem, Inc. en Malignant Pleural Mesothelioma (del registro, en inglés).

Fase

Fase 2

Estado

Interrumpido

Participantes

344

previstos

Centros

73

Fin del objetivo primario

ene 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en sep 2013.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Interim analysis-DSMB stated good safety profile but lack of efficacy».

Qué mide

Compare the overall survival (OS) in subjects with malignant pleural mesothelioma receiving defactinib (VS-6063) or placebo (From randomization to end of life, an expected average of 12 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the study, each subject must have tumor Merlin status(high or low) established by immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1 ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be stratified by tumor Merlin status (high versus low). Progression will be assessed both locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Subjects will continue to receive treatment until disease progression or other discontinuation criteria are met. Following documentation of nonfatal disease progression, all subjects will be followed for overall survival by telephone contact every 2 months until end of life or the close of the study.

Más ensayos de VSTM

Todos los de VSTM, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01870609), actualizada en ene 2017.