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 InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Rhode Island HospitalProvidence, Rhode Island  02903
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
Central Baptist HospitalLexington, Kentucky  40503
Mount Sinai Medical CenterNew York, New York  10029
Carle Cancer CenterUrbana, Illinois  61801
St. John's HospitalMaplewood, Minnesota  55109
Regions HospitalSaint Paul, Minnesota  55101
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Sharp Memorial HospitalSan Diego, California  92123
St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
Duke University Medical CenterDurham, North Carolina  27710
Georgetown UniversityWashington, District of Columbia  20007-2197
Henry Ford Health SystemDetroit, Michigan  48202
Metro Minnesota CCOPSt. Louis Park, Minnesota  55416
Lahey ClinicBurlington, Massachusetts  01805
Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
UC Davis Comprehensive Cancer CenterSacramento, California  95817
Hematology Oncology Associates of the Treasure CoastPort St. Lucie, Florida  34952
Colorado Cancer Research ProgramDenver, Colorado  80224
Medical and Surgical SpecialistsGalesburg, Illinois  61401
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Cancer Center of KansasWichita, Kansas  67214
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Christiana Care Health ServicesNewark, Delaware  19713
Presbyterian Hospital Cancer CenterCharlotte, North Carolina  28204
Central Coast Medical OncologySanta Maria, California  93454
The Miriam HospitalProvidence, Rhode Island  02903
Suburban Hematology-Oncology Assoc., PCLawrenceville, Georgia  30045
St. Jude Heritage HealthcareFullerton, California  92835
John Hopkins UniversityBaltimore, Maryland  21231
Pharma ResourceEast Providence, Rhode Island  02915
Suburban Hematology-Oncology Associates, P.C.Lawrenceville, Georgia  30045
Weinberg Cancer Institute at Franklin SquareBaltimore, Maryland  21237
Ingalls Cancer Research CenterHarvey, Illinois  60426
St. Mary's Hospital Regional Cancer CenterGrand Junction, Colorado  81502
Illinois CancerCare, P.C.Bloomington, Illinois  61701
Cancer Care Centers of BrevardRockledge, Florida  32955
Mercy Cancer CenterToledo, Ohio  43623
Compass Research, LLCOrlando, Florida  32806
Central Hem/Onc Medical Group, Inc.Alhambra, California  91801
Providence St. Joseph Medical Center-Disney Family Cancer CenterBurbank, California  91505
The Thomas and Dorothy Leavey Cancer Center Northridge Hospital Medical CenterNorthridge, California  91328
CPMCRI / Pacific Hematology Oncology AssociatesSan Francisco, California  94115
Lutheran Hematology & OncologyWheat Ridge, Colorado  80033
Integrated Community Oncology Network / Cancer Specialists of North FloridaJacksonville, Florida  32256
Mayo Clinic Florida Hematology/OncologyJacksonville, Florida  32224
H. Lee Moffitt Cancer Center (Moffitt Cancer Center)Tampa, Florida  33612
Oncology Specialists,S.C. Center for Advanced CarePark 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 CCOPDuluth, Minnesota  55805
Coborn Cancer Center/ CentraCare Health PlazaSt. Cloud, Minnesota  56303
CCCNLas Vegas, Nevada  89169
Piedmont Hematology Oncology Associates PAWinston Salem, North Carolina  27103
Medcenter OneBismarck, North Dakota  58501
TriHealth Oncology Institute/Oncology Partners NetworkCincinnati, Ohio  45247
Hickman Cancer Center at Flower HospitalSylvania, Ohio  43560
St. Vincent Hospital / Green Bay OncologyGreen Bay, Wisconsin  54301
St. Mary's Hospital / Green Bay OncologyGreen Bay, Wisconsin  54303
UCLA Hematology OncologySanta Monica, California  90404