Active Clinical Trials

A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma

By April 24, 2017 No Comments

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

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