Clinical trial NCT01507545: Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Colorectal Cancer
Keywords: mCRC
chemorefractory metastatic colorectal cancer
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2012-01-11
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From the date of randomization to the date of the first observation of PD or death due to any cause (up to approximately 1 year 7 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of randomization to the date of death due to any cause (up to approximately 1 year 7 months)
measure: Overall Response Rate (ORR)
timeFrame: From the date of randomization to the first documentation of CR or PR (up to approximately 1 year 7 months)
measure: Time to Tumor Response (TTR)
timeFrame: From the date of randomization to first documentation of objective tumor response (CR or PR) (up to approximately 1 year 7 months)
measure: Duration of Response (DOR)
timeFrame: From the date of first objective response (CR or PR) to objective tumor progression or death regardless of cause (up to approximately 1 year 7 months)
measure: Biomarkers Based PFS, Within Treatment Group
timeFrame: From the date of randomization up to approximately 1 year 7 months
measure: Biomarkers Based OS, Within Treatment Group
timeFrame: From the date of randomization up to approximately 1 year 7 months
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: Central Hem/Onc Medical Group, Inc.
state: California
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Burbank
country: United States
facility: Providence St. Joseph Medical Center-Disney Family Cancer Center
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Healthcare
state: California
city: Northridge
country: United States
facility: The Thomas and Dorothy Leavey Cancer Center Northridge Hospital Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: CPMCRI / Pacific Hematology Oncology Associates
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology Oncology
state: California
city: Denver
country: United States
facility: Colorado Cancer Research Program
state: Colorado
city: Grand Junction
country: United States
facility: St. Mary's Hospital Regional Cancer Center
state: Colorado
city: Wheat Ridge
country: United States
facility: Lutheran Hematology & Oncology
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Florida Hematology/Oncology
state: Florida
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network / Cancer Specialists of North Florida
state: Florida
city: Orange City
country: United States
facility: Compass Research, LLC
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Rockledge
country: United States
facility: Cancer Care Centers of Brevard
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center (Moffitt Cancer Center)
state: Florida
city: Duluth
country: United States
facility: Suburban Hematology-Oncology Associates, P.C.
state: Georgia
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology Assoc., PC
state: Georgia
city: Snellville
country: United States
facility: Suburban Hematology-Oncology Associates, P.C.
state: Georgia
city: Galesburg
country: United States
facility: Medical and Surgical Specialists
state: Illinois
city: Harvey
country: United States
facility: Ingalls Cancer Research Center
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists,S.C. Center for Advanced Care
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare, P.C.
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Clive
country: United States
facility: Medical Oncology & Hematology Associates (Clinic #3)
state: Iowa
city: Des Moines
country: United States
facility: Iowa Oncology Research Association
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology & Hematology Associates (Clinic #1)
state: Iowa
city: Des Moines
country: United States
facility: Medical Oncology & Hematology Associates (Clinic #2)
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates, LLP
state: Iowa
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Baltimore
country: United States
facility: Weinberg Cancer Institute at Franklin Square
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Grand Rapids Clinical Oncology Program
state: Michigan
city: Duluth
country: United States
facility: Essentia Health Duluth CCOP
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Cloud
country: United States
facility: Coborn Cancer Center/ CentraCare Health Plaza
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota CCOP
state: Minnesota
city: Saint Louis Park
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Louis Park
country: United States
facility: St. John's Hospital
state: Minnesota
city: Las Vegas
country: United States
facility: CCCN
state: Nevada
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Hematology Oncology Associates PA
state: North Carolina
city: Bismarck
country: United States
facility: Medcenter One
state: North Dakota
city: Cincinnati
country: United States
facility: TriHealth Oncology Institute/Oncology Partners Network
state: Ohio
city: Sylvania
country: United States
facility: Hickman Cancer Center at Flower Hospital
state: Ohio
city: Toledo
country: United States
facility: Mercy Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: East Providence
country: United States
facility: Pharma Resource
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Green Bay
country: United States
facility: St. Vincent Hospital / Green Bay Oncology
state: Wisconsin
city: Green Bay
country: United States
facility: St. Mary's Hospital / Green Bay Oncology
state: Wisconsin
Study officials:
References: