A Randomized, Double-Blind, Placebo-controlled Study of the Efficacy & Safety of Monotherapy MORAb-004 Plus Best Supportive Care in Subjects With Chemorefractory Metastatic Colorectal Cancer
Colorectal cancer is the third most common new cancer diagnosis by 2011 estimates and, by
far, the most common digestive system cancer. The number of anticipated new cases in 2011
in the US is 141,210, being equally distributed between men and women. Tumor endothelial
marker-1 also referred to as TEM-1 is expressed in the supportive tissue, as well as, on the
cells within the tumor. TEM-1, which is a cell surface glycoprotein, and is expressed in
the stromal compartment (cells) of nearly all human tumors. In preclinical studies, it has
been shown that TEM-1 plays a key role in tumor growth and the vascularization of tumors.
There is evidence suggesting an association between the level of TEM-1, 7, 7R, 8 in relation
to lymph node involvement and disease progression. MORAb-004 is a humanized immunoglobulin
G (IgG1/κ) antibody directed against endosialin/TEM-1. Nonclinical pharmacological studies
showed that MORAb-004 has the ability to block specific TEM-1 receptor-ligand interactions.
Immunohistochemistry studies of human tumor biopsy samples demonstrate TEM-1 expression and
MORAb-004 binding to tumor stromal cells, in particular mural cell compartment of neovessels
and cancer-associated fibroblasts. All of which suggests a potential effective treatment.
Researchers hypothesize that an antibody therapy which binds to TEM-1 may be efficacious in
the treatment of metastatic, colorectal cancer. This clinical trial is a proof of concept
study to see if an anti-TEM-1 agent is safe and effective in the treatment of metastatic,
colorectal cancer.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression-free survival
after 107 subjects have experienced disease progression or died prior to exhibiting disease progression
16 wks after last patient enrolled
No
John Heyburn
Study Director
Morphotek, Inc.
United States: Food and Drug Administration
MORAb-004-202-CRC
NCT01507545
March 2012
November 2013
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Mount Sinai Medical Center | New York, New York 10029 |
Carle Cancer Center | Urbana, Illinois 61801 |
St. John's Hospital | Maplewood, Minnesota 55109 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
Sharp Memorial Hospital | San Diego, California 92123 |
St. Joseph Mercy Hospital | Pontiac, Michigan 48341-2985 |
Duke University Medical Center | Durham, North Carolina 27710 |
Georgetown University | Washington, District of Columbia 20007-2197 |
Henry Ford Health System | Detroit, Michigan 48202 |
Metro Minnesota CCOP | St. Louis Park, Minnesota 55416 |
Lahey Clinic | Burlington, Massachusetts 01805 |
Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Hematology Oncology Associates of the Treasure Coast | Port St. Lucie, Florida 34952 |
Colorado Cancer Research Program | Denver, Colorado 80224 |
Medical and Surgical Specialists | Galesburg, Illinois 61401 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Cancer Center of Kansas | Wichita, Kansas 67214 |
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
Christiana Care Health Services | Newark, Delaware 19713 |
Presbyterian Hospital Cancer Center | Charlotte, North Carolina 28204 |
Central Coast Medical Oncology | Santa Maria, California 93454 |
The Miriam Hospital | Providence, Rhode Island 02903 |
Suburban Hematology-Oncology Assoc., PC | Lawrenceville, Georgia 30045 |
St. Jude Heritage Healthcare | Fullerton, California 92835 |
John Hopkins University | Baltimore, Maryland 21231 |
Pharma Resource | East Providence, Rhode Island 02915 |
Suburban Hematology-Oncology Associates, P.C. | Lawrenceville, Georgia 30045 |
Weinberg Cancer Institute at Franklin Square | Baltimore, Maryland 21237 |
Ingalls Cancer Research Center | Harvey, Illinois 60426 |
St. Mary's Hospital Regional Cancer Center | Grand Junction, Colorado 81502 |
Illinois CancerCare, P.C. | Bloomington, Illinois 61701 |
Cancer Care Centers of Brevard | Rockledge, Florida 32955 |
Mercy Cancer Center | Toledo, Ohio 43623 |
Compass Research, LLC | Orlando, Florida 32806 |
Central Hem/Onc Medical Group, Inc. | Alhambra, California 91801 |
Providence St. Joseph Medical Center-Disney Family Cancer Center | Burbank, California 91505 |
The Thomas and Dorothy Leavey Cancer Center Northridge Hospital Medical Center | Northridge, California 91328 |
CPMCRI / Pacific Hematology Oncology Associates | San Francisco, California 94115 |
Lutheran Hematology & Oncology | Wheat Ridge, Colorado 80033 |
Integrated Community Oncology Network / Cancer Specialists of North Florida | Jacksonville, Florida 32256 |
Mayo Clinic Florida Hematology/Oncology | Jacksonville, Florida 32224 |
H. Lee Moffitt Cancer Center (Moffitt Cancer Center) | Tampa, Florida 33612 |
Oncology Specialists,S.C. Center for Advanced Care | Park Ridge, Illinois 60068 |
Medical Oncology & Hematology Associates (Clinic #3) | Clive, Iowa 50325 |
Medical Oncology & Hematology Associates (Clinic #1) | Des Moines, Iowa 50309 |
Medical Oncology & Hematology Associates (Clinic #2) | Des Moines, Iowa 50314 |
Essentia Health Duluth CCOP | Duluth, Minnesota 55805 |
Coborn Cancer Center/ CentraCare Health Plaza | St. Cloud, Minnesota 56303 |
CCCN | Las Vegas, Nevada 89169 |
Piedmont Hematology Oncology Associates PA | Winston Salem, North Carolina 27103 |
Medcenter One | Bismarck, North Dakota 58501 |
TriHealth Oncology Institute/Oncology Partners Network | Cincinnati, Ohio 45247 |
Hickman Cancer Center at Flower Hospital | Sylvania, Ohio 43560 |
St. Vincent Hospital / Green Bay Oncology | Green Bay, Wisconsin 54301 |
St. Mary's Hospital / Green Bay Oncology | Green Bay, Wisconsin 54303 |
UCLA Hematology Oncology | Santa Monica, California 90404 |