Condition
Pleural Mesothelioma Malignant Advanced|Peritoneal Mesothelioma Malignant Advanced|Non-squamous Non-small Cell Lung Carcinoma Stage IIIB/IV (NSCLC)|Metastatic Uveal Melanoma|Hepatocellular Carcinoma (HCC)|Glioma|Sarcomatoid Cancers
Estimated Enrollment: 88
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: Treatment
Study ID Numbers: POLARIS2013-006
Study First Received: December 16, 2013
Last Updated: April 3, 2017
Estimated Primary Completion Date: August 2018
Primary Outcome Measures:
Define initial estimates of efficacy, measured by RECIST 1.1 criteria for non-squamous NSCLC, advanced peritoneal mesothelioma, metastatic uveal melanoma, HCC, glioma and sarcomatoid cancers for ADI-PEG 20 in combination with pemetrexed and cisplatin.|Define initial estimates of efficacy, measured by modified RECIST criteria for advanced MPM|Determine the MTD of ADI-PEG 20 in combination with pemetrexed and cisplatin
Sponsors and Collaborators:
Polaris Group
Website Link: https://ClinicalTrials.gov/show/NCT02029690
