Condition
Malignant Pleural Mesothelioma|Non-Small Cell Lung Cancer
Estimated Enrollment: 24
Age Group: 20 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: D8807005
Study First Received: January 21, 2015
Last Updated: July 19, 2016
Estimated Primary Completion Date: May 2017
Primary Outcome Measures:
Phase1: Assessment of safety of BBI608 given in combination with Pemetrexed and Cisplatin by reporting the adverse events and serious adverse events.|Phase1: Assessment of dose-limiting toxicities (DLTs).|Phase1: Pharmacokinetics profile of BBI608 when administered with pemetrexed and cisplatin.|Phase2: Progression Free Survival (PFS)|Phase1: Anti-tumor activity|Phase1: Progression Free Survival(PFS)|Phase1: Overall Survival(OS)|Phase2: Overall Survival (OS)|Phase2: Response Rate(RR)|Phase2: Disease Control Rate(DCR)|Phase2: Vital Capacity(VC)|Phase2: Forced vital capacity(FVC)|Phase2: Forced Expiratory Volume in 1st second(FEV1)|Phase2: Safety by reporting the adverse events and serious adverse events.
Sponsors and Collaborators:
Sumitomo Dainippon Pharma Co., Ltd.
Website Link: https://ClinicalTrials.gov/show/NCT02347917
