223
Participants
Start Date
October 12, 2015
Primary Completion Date
September 18, 2017
Study Completion Date
August 29, 2019
Low Dose GC4419: 30mg/day
Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
High Dose GC4419: 90mg/day
High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Placebo
Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy
Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin
"Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
Montefiore Medical Center, The Bronx
Allegheny General Hospital, Allegheny Cancer Center, Pittsburgh
St. Luke's University Health Network, Easton
Thomas-Jefferson University Hospital-Bodine Center for Cancer Treatment, Philadelphia
West Virginia University, Morgantown
Wake Forest Health, Winston-Salem
East Carolina University, Leo W. Jenkins Cancer Center, Greenville
Marion L. Shepard Cancer Center, Washington
Spartanburg Medical Center, Spartanburg
Charleston Cancer Center, Charleston
AnMed Health Cancer Center, Anderson
Lakeland Regional Health Cancer Center, Lakeland
Sacred Heart Medical Oncology Group, Pensacola
UF Health Cancer Center at Orlando Health, Orlando
Pasco Pinellas Cancer Center, Holiday
Mountain States Health Alliance, Johnson City
University of Tennessee Medical Center, Knoxville
University of Louisville Hospital, James Graham Brown Cancer Center, Louisville
University of Kentucky, Albert B. Chandler Medical Center, Lexington
Ashland-Bellefonte Cancer Center, Ashland
Ohio State University, James Cancer Center, Columbus
Toledo Clinic Cancer Center, Toledo
University of Indianan, Goshen Center for Cancer Care, Goshen
Lake Huron Medical Center, Port Huron
University of Michigan, Ann Arbor
Henry Ford Allegiance Health, Jackson
Department of Radiation Oncology University of Iowa Hospitals & Clinics, Iowa City
Prairie Lakes Health Care System, Watertown
Billings Clinic, Billings
St. Vincent Frontier Cancer Center, Billings
Northwestern University, Chicago
Ellis Fichel Cancer Center, University of Missouri, Columbia
University of Kansas Medical Center, Kansas City
Tulane Cancer Center, New Orleans
CHRISTUS Schumpert Cancer Treatment Center, Shreveport
University of Arkansas for Medical Sciences- Winthrop P. Rockefeller Cancer Institute, Little Rock
Fowler Family Center for Cancer Care, Jonesboro
Texas Oncology, Plano
Hope Cancer Center, Tyler
Scott and White Memorial Hospital and Clinic, Temple
St. Mary's Regional Cancer Center, Grand Junction
University of Arizona Cancer Center at Dignity Health St. Joseph's, Phoenix
University of Arizona, Tucson
Renown Cancer Institute, Reno
USC Norris Comprehensive Cancer Center, Los Angeles
Clinical Trials and Research Associates, Inc., Montebello
VA Long Beach Healthcare System, Long Beach
UC Irvine Chao Family Comprehensive Cancer Center, Orange
Stanford Cancer Institute, Stanford
Oregon Health and Science University, Portland
VA Portland Health Care System, Portland
VA Puget Sound Health Care System, Seattle
Providence Regional Medical Center, Everett
Cancer Care Northwest, Spokane
UConn Health School of Dental Medicine, Farmington
Baystate Regional Cancer Program, Springfield
Hunterdon Hematology Oncology, LLC Hunterdon Regional Cancer Center, Flemington
Jersey Shore University Medical Center- Hackensack Meridian Health, Neptune City
Rhode Island Hospital, Providence
The University of Vermont Medical Center, Burlington
Northeast Cancer Centre, Health Sciences North, Greater Sudbury
Jewish General Hospital, Montreal
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-centre-du-Québec, Trois-Rivières
Fundación de Investigación, San Juan
Lead Sponsor
Galera Therapeutics, Inc.
INDUSTRY