Recruiting Clinical Trials

Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

By April 24, 2017 No Comments

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

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