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

NCT ID: NCT01507545

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-27
• Study Completion Date: 2013-10-20

Brief Summary

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

Detailed Description

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 that binds to TEM-1 may be efficacious in the treatment of metastatic, colorectal cancer. This clinical study 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.

Conditions

Metastatic Colorectal Cancer; Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MORAb-004

Group Type: ACTIVE_COMPARATOR

MORAb-004

Intervention Type: DRUG

MORAb-004 8mg per kg IV once a week

Best supportive care

Intervention Type: OTHER

Best supportive care to improve quality of life

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo - normal saline IV once a week

Best supportive care

Intervention Type: OTHER

Best supportive care to improve quality of life

Interventions

MORAb-004

MORAb-004 8mg per kg IV once a week

Intervention Type: DRUG

Placebo

Placebo - normal saline IV once a week

Intervention Type: DRUG

Best supportive care

Best supportive care to improve quality of life

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Morphotek

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Central Hem/Onc Medical Group, Inc.

Alhambra, California, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Providence St. Joseph Medical Center-Disney Family Cancer Center

Burbank, California, United States

St. Jude Heritage Healthcare

Fullerton, California, United States

The Thomas and Dorothy Leavey Cancer Center Northridge Hospital Medical Center

Northridge, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Sharp Memorial Hospital

San Diego, California, United States

CPMCRI / Pacific Hematology Oncology Associates

San Francisco, California, United States

Central Coast Medical Oncology

Santa Maria, California, United States

UCLA Hematology Oncology

Santa Monica, California, United States

Colorado Cancer Research Program

Denver, Colorado, United States

St. Mary's Hospital Regional Cancer Center

Grand Junction, Colorado, United States

Lutheran Hematology & Oncology

Wheat Ridge, Colorado, United States

Christiana Care Health Services

Newark, Delaware, United States

Georgetown University

Washington D.C., District of Columbia, United States

Mayo Clinic Florida Hematology/Oncology

Jacksonville, Florida, United States

Integrated Community Oncology Network / Cancer Specialists of North Florida

Jacksonville, Florida, United States

Compass Research, LLC

Orange City, Florida, United States

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Cancer Care Centers of Brevard

Rockledge, Florida, United States

H. Lee Moffitt Cancer Center (Moffitt Cancer Center)

Tampa, Florida, United States

Suburban Hematology-Oncology Associates, P.C.

Duluth, Georgia, United States

Suburban Hematology-Oncology Assoc., PC

Lawrenceville, Georgia, United States

Suburban Hematology-Oncology Associates, P.C.

Snellville, Georgia, United States

Medical and Surgical Specialists

Galesburg, Illinois, United States

Ingalls Cancer Research Center

Harvey, Illinois, United States

Oncology Specialists,S.C. Center for Advanced Care

Park Ridge, Illinois, United States

Illinois CancerCare, P.C.

Peoria, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Medical Oncology & Hematology Associates (Clinic #3)

Clive, Iowa, United States

Iowa Oncology Research Association

Des Moines, Iowa, United States

Medical Oncology & Hematology Associates (Clinic #1)

Des Moines, Iowa, United States

Medical Oncology & Hematology Associates (Clinic #2)

Des Moines, Iowa, United States

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Central Baptist Hospital

Lexington, Kentucky, United States

John Hopkins University

Baltimore, Maryland, United States

Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, United States

Lahey Clinic

Burlington, Massachusetts, United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, United States

Essentia Health Duluth CCOP

Duluth, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Coborn Cancer Center/ CentraCare Health Plaza

Saint Cloud, Minnesota, United States

Metro Minnesota CCOP

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Louis Park, Minnesota, United States

St. John's Hospital

Saint Louis Park, Minnesota, United States

CCCN

Las Vegas, Nevada, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Mount Sinai Medical Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Presbyterian Hospital Cancer Center

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Piedmont Hematology Oncology Associates PA

Winston-Salem, North Carolina, United States

Medcenter One

Bismarck, North Dakota, United States

TriHealth Oncology Institute/Oncology Partners Network

Cincinnati, Ohio, United States

Hickman Cancer Center at Flower Hospital

Sylvania, Ohio, United States

Mercy Cancer Center

Toledo, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Pharma Resource

East Providence, Rhode Island, United States

Rhode Island Hospital

Providence, Rhode Island, United States

The Miriam Hospital

Providence, Rhode Island, United States

St. Vincent Hospital / Green Bay Oncology

Green Bay, Wisconsin, United States

St. Mary's Hospital / Green Bay Oncology

Green Bay, Wisconsin, United States

Countries

United States

Other Identifiers

MORAb-004-202-CRC

Identifier Type: -

Identifier Source: org_study_id