Spots Global Cancer Trial Database for A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
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Trial Identification
Brief Title: A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas
Official Title: A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of PRT811 in Subjects With Advanced Solid Tumors, CNS Lymphoma, and Recurrent High-Grade Gliomas
Study ID: NCT04089449
Interventions
Study Description
Brief Summary: This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase (PRMT) 5 inhibitor, in subjects with advanced cancers and high-grade gliomas who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT811.
Detailed Description: This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of PRT811, a PRMT5 inhibitor, in subjects with advanced cancers without any approved or available treatment options including solid tumors, CNS lymphoma, and /or high-grade gliomas. The study will consist of 2 parts, a dose escalation part evaluating subjects with advanced solid tumors, CNS lymphoma, and/or high-grade glioma and a cohort expansion part which will evaluate the safety and efficacy of PRT811 in subjects with advanced solid tumors, and glioblastoma multiforme. For subjects, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of PRT811.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
Yale- New Haven Hospital- Yale Cancer Center, New Haven, Connecticut, United States
Christiana Care Health Services, Christiana Hospital, Newark, Delaware, United States
Florida Cancer Specialists, Lake Mary, Florida, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
The Ohio State University and Wexner Medical Center, Columbus, Ohio, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States
Tennessee Oncology, Nashville, Tennessee, United States
Contact Details
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