Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer, Colorectal Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- Males and females >18 years old

- Diagnosis of metastatic, colorectal cancer

- Significant medical conditions must be well-controlled and stable for at least 30
days prior to the first treatment infusion

- Be willing and able to provide written informed consent

Exclusion Criteria:

- No prior treatment for metastatic colorectal cancer

- Other serious systemic diseases (bacterial or fungal)

- Clinically significant heart disease or an arrhythmia on an ECG within the past 6
months

- Known allergic reaction to monoclonal antibody therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

after 107 subjects have experienced disease progression or died prior to exhibiting disease progression

Outcome Time Frame:

16 wks after last patient enrolled

Safety Issue:

No

Principal Investigator

John Heyburn

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

MORAb-004-202-CRC

NCT ID:

NCT01507545

Start Date:

March 2012

Completion Date:

November 2013

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Cancer
  • mCRC
  • chemorefractory metastatic colorectal cancer
  • Colorectal Neoplasms

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