Condition
Cancer
Estimated Enrollment: 34
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: 114746
Study First Received: September 5, 2013
Last Updated: January 16, 2017
Estimated Primary Completion Date: June 2016
Primary Outcome Measures:
Part 1: Safety assessment as assessed by adverse events (AEs) and serious adverse events (SAEs)|Part 1: Safety assessment as assessed by 12-lead electrocardiogram (ECG)|Part 1: Safety assessment as assessed by vital signs|Part 1: Safety assessment as assessed by change from baseline in laboratory values|Part 1: Safety assessment as assessed by echocardiogram|Part 1: Safety assessment as assessed by eye examination|Part 1: Safety assessment as assessed by urine protein to creatinine (UPC) ratio|Part 2: Long term safety assessment as assessed by AEs and SAEs|Part 2: Long term safety assessment as assessed by 12-lead ECG|Part 2: Long term safety assessment as assessed by vital signs|Part 2: Long term safety assessed as change from baseline in laboratory values|Part 2: Long term safety assessment as assessed by echocardiogram|Part 2: Long term safety assessment as assessed by eye examination|Part 2: Long term safety assessment as assessed by UPC ratio|Part 1: GSK2256098 and trametinib PK assessment following repeat-dose (Day 15) administration of GSK2256098 and trametinib|Part 1: Tumor response and analysis of change from baseline levels of PD markers including pFAK/FAK, and pERK/ERK measured in tumor biopsies|Part 2: Tumor response as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) for mesothelioma|Part 2: Change from baseline in observer assessed components of the Lung cancer symptom scale (LCSS)-mesothelioma|Part 2: Change from baseline in forced vital capacity|Part 2: Progression-free survival (PFS)|Part 2: Change from baseline in patient reported components of the LCSS-mesothelioma|Part 2: GSK2256098 and trametinib PK parameters following repeat-dose (Day 22) administration of GSK2256098 and trametinib|Part 2: Exploratory analysis between PK parameters, change from baseline levels of PD markers including pFAK/FAK, pERK/ERK measured in tumor biopsies, and tumor response|Part 1 and 2: GSK2256098 dried blood spot (DBS) and whole blood PK parameter following repeat-dose (Day15 and 22) administration of GSK2256098 and trametinib
Sponsors and Collaborators:
GlaxoSmithKline
Website Link: https://ClinicalTrials.gov/show/NCT01938443
