Condition
Cancer
Estimated Enrollment: 120
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Treatment
Study ID Numbers: 117360
Study First Received: May 30, 2013
Last Updated: April 7, 2017
Estimated Primary Completion Date: April 14, 2017
Primary Outcome Measures:
Rate and severity of adverse events (AEs) as a measure of safety and tolerability|Number of Participants withdrawn due to AEs as measure of safety and tolerability|Dose interruptions and reduction as a measure of safety and tolerability|Treatment duration as a measure of safety and tolerability|Dose limiting toxicity (DLT) as a measure of safety and tolerability|Change from baseline in vital sign as a measure of safety and tolerability|Change from baseline in 12-lead electrocardiogram (ECG) as a measure of safety and tolerability|Change from baseline in Echocardiogram (ECHO) as measure of safety and tolerability|Change from baseline in laboratory test as measure of safety and tolerability|Maximum tolerated dose (MTD) or maximum feasible dose (MFD) of GSK3052230 in arm A and B|Best response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1|Overall response rate (ORR) per RECIST 1.1 or modified RECIST|Change from baseline in physical examination parameters|Progression-free survival (PFS) by investigator assessment per RECIST 1.1 or modified RECIST|GSK3052230 population pharmacokinetic (PK) profile|Change from baseline in Forced Vital Capacity (FVC) in subjects with MPM
Sponsors and Collaborators:
GlaxoSmithKline
Website Link: https://ClinicalTrials.gov/show/NCT01868022
