Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01507545
First received: December 5, 2011
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe in the treatment of metastatic, colorectal cancer.


Condition Intervention Phase
Metastatic Colorectal Cancer
Colorectal Cancer
Drug: MORAb-004
Drug: Placebo
Phase 2

Study Type: 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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 16 wks after last patient enrolled ] [ Designated as safety issue: No ]
    after 107 subjects have experienced disease progression or died prior to exhibiting disease progression


Secondary Outcome Measures:
  • Timeframe between first treatment until death for all subjects [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]
    Overall survival will be measured from first treatment until time to event (death).

  • Number of subjects with adverse events [ Time Frame: 20 Months ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be measured by number of adverse events, ECG results, vital sign assessments, and review of laboratory tests.

  • Quality of Life [ Time Frame: 20 Months ] [ Designated as safety issue: Yes ]
    Quality of Life will be measured by reviewing responses on questionaaires about how the subject is feeling.

  • Overall response rate based on RECIST criteria [ Time Frame: 20 Months ] [ Designated as safety issue: Yes ]
    Overall response rate will be measured by the investigator's assessment of how the subject is responding to the study treatment in regards to the RECISIT criteria.


Enrollment: 126
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MORAb-004 Drug: MORAb-004
MORAb-004 8mg IV per kg once a week
Placebo Comparator: Placebo Drug: Placebo
Placebo - normal saline IV once a week

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507545

  Hide Study Locations
Locations
United States, California
Central Hem/Onc Medical Group, Inc.
Alhambra, California, United States, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Providence St. Joseph Medical Center-Disney Family Cancer Center
Burbank, California, United States, 91505
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
The Thomas and Dorothy Leavey Cancer Center Northridge Hospital Medical Center
Northridge, California, United States, 91328
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States, 92123
CPMCRI / Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
Central Coast Medical Oncology
Santa Maria, California, United States, 93454
UCLA Hematology Oncology
Santa Monica, California, United States, 90404
United States, Colorado
Colorado Cancer Research Program
Denver, Colorado, United States, 80224
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States, 81501
Lutheran Hematology & Oncology
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
Integrated Community Oncology Network / Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256
Mayo Clinic Florida Hematology/Oncology
Jacksonville, Florida, United States, 32224
Compass Research, LLC
Orange City, Florida, United States, 32763
Hematology Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, United States, 34952
Cancer Care Centers of Brevard
Rockledge, Florida, United States, 32955
H. Lee Moffitt Cancer Center (Moffitt Cancer Center)
Tampa, Florida, United States, 33612
United States, Georgia
Suburban Hematology-Oncology Associates, P.C.
Duluth, Georgia, United States, 30096
Suburban Hematology-Oncology Assoc., PC
Lawrenceville, Georgia, United States, 30046
Suburban Hematology-Oncology Associates, P.C.
Snellville, Georgia, United States, 30078
United States, Illinois
Medical and Surgical Specialists
Galesburg, Illinois, United States, 61401
Ingalls Cancer Research Center
Harvey, Illinois, United States, 60426
Oncology Specialists,S.C. Center for Advanced Care
Park Ridge, Illinois, United States, 60068
Illinois CancerCare, P.C.
Peoria, Illinois, United States, 61615
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
Medical Oncology & Hematology Associates (Clinic #3)
Clive, Iowa, United States, 50325
Medical Oncology & Hematology Associates (Clinic #2)
Des Moines, Iowa, United States, 50314
Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Medical Oncology & Hematology Associates (Clinic #1)
Des Moines, Iowa, United States, 50309
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
Cancer Center of Kansas
Wichita, Kansas, United States, 67208
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Maryland
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, United States, 21237
John Hopkins University
Baltimore, Maryland, United States, 21231-1000
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Henry Ford Health System
Detroit, Michigan, United States, 48202
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Essentia Health Duluth CCOP
Duluth, Minnesota, United States, 55805
Mayo Clinic
Rochester, Minnesota, United States, 55905
St. John's Hospital
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Louis Park, Minnesota, United States, 55416
Metro Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Coborn Cancer Center/ CentraCare Health Plaza
St. Cloud, Minnesota, United States, 56303
United States, Nevada
CCCN
Las Vegas, Nevada, United States, 89169
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Presbyterian Hospital Cancer Center
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
Piedmont Hematology Oncology Associates PA
Winston Salem, North Carolina, United States, 27103
United States, North Dakota
Medcenter One
Bismarck, North Dakota, United States, 58501
United States, Ohio
TriHealth Oncology Institute/Oncology Partners Network
Cincinnati, Ohio, United States, 45247
Hickman Cancer Center at Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Cancer Center
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Rhode Island
Pharma Resource
East Providence, Rhode Island, United States, 02915
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Wisconsin
St. Mary's Hospital / Green Bay Oncology
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital / Green Bay Oncology
Green Bay, Wisconsin, United States, 54301
Sponsors and Collaborators
Morphotek
Investigators
Study Director: John Heyburn Morphotek, Inc.
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01507545     History of Changes
Other Study ID Numbers: MORAb-004-202-CRC
Study First Received: December 5, 2011
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Morphotek:
mCRC
chemorefractory metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014