A Randomized Cross-over Phase 2 Study of the Safety and Efficacy of Two Dose Levels of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma
A hypoxic microenvironment is a characteristic of many solid tumors including pancreatic
cancer. 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 physiologically target the hypoxic microenvironment. There is an absence of
therapeutic options for subjects with metastatic pancreatic cancer. Gemcitabine provides
clinical benefit as a single agent, but median survival is about 6 months. Combining
gemcitabine with TH-302 may enable the targeting of both the normoxic and hypoxic regions of
pancreatic cancer.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
No
Mitesh Borad, MD
Principal Investigator
Mayo Clinic
United States: Food and Drug Administration
TH-CR-404
NCT01144455
June 2010
January 2012
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Ocala Oncology Center | Ocala, Florida 34474 |
University of Texas Southwestern Medical Center at Dallas | Dallas, Texas 75235-8897 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Carle Cancer Center | Urbana, Illinois 61801 |
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
Palo Alto Medical Foundation | Palo Alto, California 94301 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
Sharp Memorial Hospital | San Diego, California 92123 |
Martin Memorial Cancer Center | Stuart, Florida 34995-9010 |
Ochsner Cancer Institute | New Orleans, Louisiana 70121 |
Atlanta Cancer Care | Atlanta, Georgia 30342 |
University of Arizona | Tucson, Arizona 85724 |
Duke University Medical Center | Durham, North Carolina 27710 |
New York Oncology Hematology, P.C. | Albany, New York 12208 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
California Pacific Medical Center | San Francisco, California 94115 |
University of Wisconsin | Madison,, Wisconsin 53792-5666 |
Mayo Clinic Arizona | Scottsdale, Arizona 85259 |
Saint Edward Mercy Medical Center | Ft. Smith, Arkansas 72903 |
Mayo Clinic Rochester | Rochester, Minnesota 55905 |
Birmingham Hematology and Oncology Associates, LLC | Birmingham, Alabama 35235 |
Fairfax Northern Virginia Hematology Oncology, PC | Fairfax, Virginia 22031 |
Medical Oncology | Baton Rouge, Louisiana 70809 |
Montana Cancer Institute Foundation | Missoula, Montana 59802 |
Texas Oncology-Seton Williamson | Round Rock, Texas 78665 |
Northwest Cancer Specialists, P.C. | Portland, Oregon 97227 |
University of Massachusetts Medical Center | Worcester, Massachusetts 01605 |
Florida Cancer Institute - New Hope | New Port Richey, Florida 34655 |
Signal Point Clinical Research Center | Middletown, Ohio 45042 |
Purchase Cancer Group | Paducah, Kentucky 42002 |
Cancer Care of Western North Carolina, PA | Asheville, North Carolina 28801 |
Kaiser Permanente Northwest Region Oncology Hematology | Portland, Oregon 97227 |
Vanderbilt University Medical Center, Div. of Medical Oncology | Nashville, Tennessee 37232 |
Carolina Oncology Specialists, PA | Hickory, North Carolina 28602 |
Arizona Oncology Associates, PC - HOPE | Tucson, Arizona 85704 |
Texas Oncology-Dallas Presbyterian Hospital | Dallas, Texas 75231 |
Disney Family Cancer Center | Burbank, California 91505 |
Scripps Clinical Research Services | La Jolla, California 92037 |
Los Palos Oncology and Hematology | Salinas, California 93901 |
Hematology Oncology Associates, PC | Stamford, Connecticut 06902 |
Indiana University Melvin and Bren Simon Cancer | Indianapolis, Indiana 46202 |
LSU Health Sciences Center - Feist Weiller Cancer Center | Shreveport, Louisiana 71130 |
Virgina Piper Cancer Institute | Minneapolis, Minnesota 55407 |
Hematology and Oncology Associates at BridgePoint | Tupelo, Mississippi 38801 |
Alamance Oncology Hematolgy Associates | Burlington, North Carolina 27599 |
Emerywood Hematology and Oncology | High Point, North Carolina 27262 |
Greater Philadelphia Cancer and Hematology Specialists, P.C. | Philadelphia, Pennsylvania 19114 |
Institute for Translational Oncology Research (ITOR) | Greenville, South Carolina 29605 |
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center | Beaumont, Texas 77702 |
Texas Oncology- Fort Worth - 12th Avenue | Fort Worth, Texas 76104 |
Texas Oncology-Sherman | Sherman, Texas 75090 |
Texas Oncology-Wichita Falls Texoma Cancer Center | Wichita Fall, Texas 76310 |
Providence Everett Regional Medical Center, Cancer Research Dept. | Everett, Washington 98201 |
Columbia Basin Hematology and Oncology0 | Kennewick, Washington 99336 |