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Brief Title: A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1
Study ID: NCT03776071
Brief Summary: This study will be conducted as a randomized, double-blind, placebo-controlled, multi-center Phase 3 study. Approximately 300 subjects with newly diagnosed glioblastoma who meet all eligibility criteria will be enrolled.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Barrow Neurological Institute, Phoenix, Arizona, United States
Mayo Clinic - Arizona, Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center - Duarte, Duarte, California, United States
University of California San Diego Moores Cancer Center, La Jolla, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
University of California Irvine Health Chao Family Comprehensive Cancer Center, Orange, California, United States
The University of Southern California, Pasadena, California, United States
University of California San Francisco Helen Diller Family Comprehensive CA Ctr, San Francisco, California, United States
University of Colorado Hospital Anschutz Cancer Pavilion, Aurora, Colorado, United States
Blue Sky Neurology, Englewood, Colorado, United States
Smilow Cancer Hospital - New Haven, New Haven, Connecticut, United States
Lynn Cancer Institute, Boca Raton, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Kentucky Markey Cancer Center, Lexington, Kentucky, United States
Norton Cancer Institute - Multidisciplinary Clinic, Louisville, Kentucky, United States
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
John Nasseff Neuroscience Institute, Minneapolis, Minnesota, United States
Masonic Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Washington University School of Medicine Center for Advanced Medicine, Saint Louis, Missouri, United States
Hackensack Meridian Health - JFK Medical Center, Edison, New Jersey, United States
New York University Medical Oncology Associates, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
New York - Presbyterian - Weill Cornell Medical Center, New York, New York, United States
Messino Cancer Centers, Asheville, North Carolina, United States
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Wake Forest Baptist Health - Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
The Ohio State University - The James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States
Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Penn Medicine - Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
SCRI - Tennessee Oncology - Nashville - Centennial, Nashville, Tennessee, United States
Vanderbilt - Ingram Cancer Center, Nashville, Tennessee, United States
Austin Cancer Center - Park St. David's, Austin, Texas, United States
Baylor University Medical Center, Dallas, Texas, United States
Lynn Cancer Institute, Houston, Texas, United States
University of Texas Health Science Center at Houston (UT Health), Houston, Texas, United States
Mays Cancer Center, San Antonio, Texas, United States
University of Utah, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency - Abbotsford, Abbotsford, British Columbia, Canada
British Columbia Cancer Agency - Victoria, Victoria, British Columbia, Canada
The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada
Hôpital Fleurimont, Sherbrooke, Quebec, Canada
Saskatoon Cancer Center, Saskatoon, Saskatchewan, Canada
First Affiliated Hospital of USTC - Anhui Provincial Hospital, Hefei, Anhui, China
Beijing Tian Tan Hospital, Capital Medical University, Beijing, Beijing, China
Sanbo Brain Hospital, Capital Medical University, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
Shenzhen Second People's Hospital, Shenzhen, Guangdong, China
Tongji Hospital, Wuhan, Hubei, China
Shengjing Hospital - Nanhu Campus, Shenyang, Liaoning, China
Tangdu Hospital, Xian, Shaanxi, China
Huashan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
Tianjin Huanhu Hospital, Jinnan, Tianjin, China
General Hospital of Tianjin Medical University, Tianjin, Tianjin, China