B2P2M2: Phase II trial of BNC105P as 2nd line chemotherapy for advanced malignant pleural mesothelioma

At present there is no standard 2nd line chemotherapy regime for patients with advanced malignant pleural mesothelioma (MPM) who progress after treatment with standard first line chemotherapy (i.e. pemetrexed and a platinum compound). BNC105P is a novel chemotherapy agent which has shown activity in MPM. In this study, BNC105P will be studied in a single arm, 2 stage, multi-centre design to determine its efficacy and safety as 2nd line chemotherapy for patients with MPM. All subjects will receive BNC105P on Day 1 and Day 8 of a 21 day cycle until unacceptable toxicity or disease progression. The primary endpoint will be tumour response, and secondary endpoints include progression-free survival, overall survival, adverse events, and quality of life. Correlative substudies will examine associations between potential biological markers and outcomes.