Open-label Phase 1/2 (Safety Lead-in) Study of Trans Sodium Crocetinate (TSC) With Concomitant Treatment of Fractionated Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Patients to Evaluate Safety and Efficacy
The overall objectives of this Phase 1/2 clinical study in newly diagnosed GBM patients are
to evaluate the safety and tolerability, efficacy, PK profile, PFS/time to disease
progression, QoL, and overall survival in adults when TSC is added to the standard of care
regimen of radiation therapy and temozolomide. All patients will receive TSC in this study.
The primary objective of the Phase 1 portion of the study is to evaluate the safety (DLT
rate) and to define the dosing regimen of TSC for the larger Phase 2 study. The primary
clinical endpoint is overall survival at 24 months and patients will be followed for up to 3
years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
24 months
No
United States: Food and Drug Administration
DP100-202
NCT01465347
February 2012
September 2016
Name | Location |
---|---|
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
North Shore University Hospital | Manhasset, New York 11030 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Baylor University Medical Center | Dallas, Texas 75246 |
Emory University Winship Cancer Institute | Atlanta, Georgia 30322 |
Forsyth Regional Cancer Center | Winston-Salem, North Carolina 27103 |
University of Kentucky Markey Cancer Center | Lexington, Kentucky 40536 |
Northwestern University Robert H. Lurie Comprehensive Cancer Center | Chicago, Illinois 60611-2941 |
St. Joseph's Medical Center Barrow Neurology Clinics | Phoenix, Arizona 85013 |
The George Washington University Medical Center | Washington, District of Columbia 20037 |
UVA Health Sciences Center Emily Couric Clinical Cancer Center | Charlottesville, Virginia 22908 |
University of Arkansas Winthrop P. Rockefeller Cancer Institute | Little Rock, Arkansas 72205 |
University of Florida McKnight Brain Institute | Gainesville, Florida 32611 |
Penn State University Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
University of Texas Health Science Center Memorial Hermann Medical Center | Houston, Texas 77030 |
Froedtert & Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |