Study Stopped
By the sponsor at the end of Stage 1 due to futility.
Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
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
1 other identifier
interventional
154
1 country
67
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2012
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2011
CompletedFirst Posted
Study publicly available on registry
January 11, 2012
CompletedStudy Start
First participant enrolled
March 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2013
CompletedResults Posted
Study results publicly available
May 6, 2022
CompletedMay 6, 2022
September 1, 2015
1.6 years
December 5, 2011
April 8, 2022
April 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression (PD) or death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of last tumor assessment without evidence of progression prior to the date of initiation of further antitumor treatment. PFS was summarized for each treatment group using Kaplan-Meier estimation curves.
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 (6)
Overall Survival (OS)
From the date of randomization to the date of death due to any cause (up to approximately 1 year 7 months)
Overall Response Rate (ORR)
From the date of randomization to the first documentation of CR or PR (up to approximately 1 year 7 months)
Time to Tumor Response (TTR)
From the date of randomization to first documentation of objective tumor response (CR or PR) (up to approximately 1 year 7 months)
Duration of Response (DOR)
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)
Biomarkers Based PFS, Within Treatment Group
From the date of randomization up to approximately 1 year 7 months
- +1 more secondary outcomes
Study Arms (2)
MORAb-004
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Morphoteklead
Study Sites (67)
Central Hem/Onc Medical Group, Inc.
Alhambra, California, 91801, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Providence St. Joseph Medical Center-Disney Family Cancer Center
Burbank, California, 91505, United States
St. Jude Heritage Healthcare
Fullerton, California, 92835, United States
The Thomas and Dorothy Leavey Cancer Center Northridge Hospital Medical Center
Northridge, California, 91328, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
CPMCRI / Pacific Hematology Oncology Associates
San Francisco, California, 94115, United States
Central Coast Medical Oncology
Santa Maria, California, 93454, United States
UCLA Hematology Oncology
Santa Monica, California, 90404, United States
Colorado Cancer Research Program
Denver, Colorado, 80224, United States
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, 81501, United States
Lutheran Hematology & Oncology
Wheat Ridge, Colorado, 80033, United States
Christiana Care Health Services
Newark, Delaware, 19713, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
Mayo Clinic Florida Hematology/Oncology
Jacksonville, Florida, 32224, United States
Integrated Community Oncology Network / Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Compass Research, LLC
Orange City, Florida, 32763, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Cancer Care Centers of Brevard
Rockledge, Florida, 32955, United States
H. Lee Moffitt Cancer Center (Moffitt Cancer Center)
Tampa, Florida, 33612, United States
Suburban Hematology-Oncology Associates, P.C.
Duluth, Georgia, 30096, United States
Suburban Hematology-Oncology Assoc., PC
Lawrenceville, Georgia, 30046, United States
Suburban Hematology-Oncology Associates, P.C.
Snellville, Georgia, 30078, United States
Medical and Surgical Specialists
Galesburg, Illinois, 61401, United States
Ingalls Cancer Research Center
Harvey, Illinois, 60426, United States
Oncology Specialists,S.C. Center for Advanced Care
Park Ridge, Illinois, 60068, United States
Illinois CancerCare, P.C.
Peoria, Illinois, 61615, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Medical Oncology & Hematology Associates (Clinic #3)
Clive, Iowa, 50325, United States
Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
Medical Oncology & Hematology Associates (Clinic #1)
Des Moines, Iowa, 50309, United States
Medical Oncology & Hematology Associates (Clinic #2)
Des Moines, Iowa, 50314, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Cancer Center of Kansas
Wichita, Kansas, 67208, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
John Hopkins University
Baltimore, Maryland, 21231-1000, United States
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Essentia Health Duluth CCOP
Duluth, Minnesota, 55805, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Coborn Cancer Center/ CentraCare Health Plaza
Saint Cloud, Minnesota, 56303, United States
Metro Minnesota CCOP
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Louis Park, Minnesota, 55416, United States
St. John's Hospital
Saint Louis Park, Minnesota, 55416, United States
CCCN
Las Vegas, Nevada, 89169, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Presbyterian Hospital Cancer Center
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Piedmont Hematology Oncology Associates PA
Winston-Salem, North Carolina, 27103, United States
Medcenter One
Bismarck, North Dakota, 58501, United States
TriHealth Oncology Institute/Oncology Partners Network
Cincinnati, Ohio, 45247, United States
Hickman Cancer Center at Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Cancer Center
Toledo, Ohio, 43623, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Pharma Resource
East Providence, Rhode Island, 02915, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
St. Vincent Hospital / Green Bay Oncology
Green Bay, Wisconsin, 54301, United States
St. Mary's Hospital / Green Bay Oncology
Green Bay, Wisconsin, 54303, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated by the sponsor at the end of Stage 1 due to futility, hence Stage 2 was not carried out.
Results Point of Contact
- Title
- Eisai Medical Information
- Organization
- Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2011
First Posted
January 11, 2012
Study Start
March 27, 2012
Primary Completion
October 20, 2013
Study Completion
October 20, 2013
Last Updated
May 6, 2022
Results First Posted
May 6, 2022
Record last verified: 2015-09