Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma

Summary

Objectives: Objectives The primary objective of this study is to: To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable malignant pleural mesothelioma (MPM) treated with alisertib The secondary objectives of this study are to: To assess the response rate (confirmed and unconfirmed complete + partial responses) To assess the progression-free survival. To assess overall survival. To evaluate the side effects and toxicities associated with this treatment regimen. To collect archival tissue, blood, pleural effusion fluid and plasma for correlative studies. Exploratory Objectives: To collect archival or new tissue, blood and pleural effusion fluid for correlative studies. Tissue biomarkers to be evaluated include aurora kinase pathway and c-myc gene amplification. Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens.

Timeline

Start

2015-05-20

Primary completion

2021-07-06

Completion

2021-07-06

Drugs

Indications