A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination With Doxorubicin vs. Doxorubicin Alone in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
TH-302 is designed to target the hypoxic regions of tumors which are generally located
distant from tumor vessels. Doxorubicin has poor tissue penetration and targets the regions
of tumors that are located in proximity to the tumor vessels. The presence of hypoxia in
solid tumors is associated with a more malignant phenotype and resistance to chemotherapy.
The hypoxia-activated prodrug, TH-302, is designed to selectively target the hypoxic
microenvironment. Soft tissue sarcomas have evidence supporting the presence of hypoxia
based on pO2 histography, F-MISO and gene expression profiling. There is an absence of
therapeutic options for subjects with soft tissue sarcoma. Combining doxorubicin with
TH-302 may enable the targeting of both the normoxic and hypoxic regions of soft tissue
sarcoma.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of TH-302 in combination with doxorubicin
Efficacy will be determined by overall survival in subjects with locally advanced unresectable or metastatic soft tissue sarcoma previously untreated with chemotherapy compared with doxorubicin alone
2 years
No
William Tap, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
TH-CR-406/SARC021
NCT01440088
September 2011
April 2015
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Georgia Cancer Specialists | Decatur, Georgia 30033 |
Washington Cancer Institute | Washington, District of Columbia 20010 |
Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania 19107 |
Duke University Medical Center | Durham, North Carolina 27710 |
Northwestern University | Chicago, Illinois 60611 |
Case Western Reserve University | Cleveland, Ohio 44106 |
University of Michigan Cancer Center | Ann Arbor, Michigan 48109 |
University Of Vermont | Burlington,, Vermont 05403 |
University of California, Los Angeles | Los Angeles, California |
Oregon Health and Science University | Portland, Oregon 97201 |
Georgetown University Hospital | Washington, District of Columbia 20007 |
Columbia University Medical Center | New York, New York 10032 |
Oncology Specialists | Park Ridge, Illinois 60068 |
Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157 |
Stanford Comprehensive Cancer Center | Stanford, California 94305 |
Sarcoma Oncology Center | Santa Monica, California 90403 |
MUSC - Hollings Cancer Center | Charleston, South Carolina 29425 |
Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |
University of Pittsburg Medical Center | Pittsburg, Pennsylvania 15213 |
South Florida Center for Gynecologic Oncology | Boca Raton, Florida 33487 |
Mayo Arizona | Scottsdale, Arizona 85259 |
USC-Norris Comprehensive Cancer Center | Los Angeles, California 90033 |
Mayo Clinic-Florida-Cancer Clinical Studies Unit | Jacksonville, Florida 32224 |
H.Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Winship Cancer Institute of Emory University, Midtown Campus | Atlanta, Georgia 30322 |
Kootenai Health - Kootenai Cancer Center | Coeur d`Alene, Idaho 83814 |
University of Iowa Health Care - University of Iowa Hospital | Iowa City, Iowa 52242 |
Dana Farber Cancer Institute Center for Sarcoma and Bone Oncology | Boston, Massachusetts 02215 |
Mayo Rochester | Rochester, Minnesota 55905 |
Montefiore | Bronx, New York 10461 |
Virginia Commonwealth Universtiy-Massey Cancer Center | Richmond, Virginia 23298 |
University of Washington Cancer Center | Seattle, Washington 98109 |
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital | Baltimore, Maryland 21287 |
Carolinas Hematology-oncology Associates-Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
The Arthur G. James Cancer Hospital and Richard J Solove Research Institue, The Ohio State University Comprehensive Cancer Center | Columbus, Ohio |