Metastatic Colorectal CancerPhase 2NCT01507545
Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
A Phase 2 study testing MORAb-004 in people with Metastatic Colorectal Cancer and Colorectal Cancer, run by Morphotek at 67 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Colorectal Cancer
- What is being tested?
- MORAb-004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 67 sitesUnited States
- Study dates
- 27 Mar 2012to 20 Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
United States67 sites
Central Hem/Onc Medical Group, Inc.
Alhambra, California, 91801
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
John Hopkins University
Baltimore, Maryland, 21231-1000
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237
Medcenter One
Bismarck, North Dakota, 58501
Roswell Park Cancer Institute
Buffalo, New York, 14263
Providence St. Joseph Medical Center-Disney Family Cancer Center
Burbank, California, 91505
Lahey Clinic
Burlington, Massachusetts, 01805
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Presbyterian Hospital Cancer Center
Charlotte, North Carolina, 28204
TriHealth Oncology Institute/Oncology Partners Network
Cincinnati, Ohio, 45247
Medical Oncology & Hematology Associates (Clinic #3)
Clive, Iowa, 50325
Colorado Cancer Research Program
Denver, Colorado, 80224
Iowa Oncology Research Association
Des Moines, Iowa, 50309
Medical Oncology & Hematology Associates (Clinic #1)
Des Moines, Iowa, 50309
Medical Oncology & Hematology Associates (Clinic #2)
Des Moines, Iowa, 50314
Henry Ford Health System
Detroit, Michigan, 48202
Suburban Hematology-Oncology Associates, P.C.
Duluth, Georgia, 30096
Essentia Health Duluth CCOP
Duluth, Minnesota, 55805
Duke University Medical Center
Durham, North Carolina, 27710
Pharma Resource
East Providence, Rhode Island, 02915
St. Jude Heritage Healthcare
Fullerton, California, 92835
Medical and Surgical Specialists
Galesburg, Illinois, 61401
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, 81501
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
St. Vincent Hospital / Green Bay Oncology
Green Bay, Wisconsin, 54301
St. Mary's Hospital / Green Bay Oncology
Green Bay, Wisconsin, 54303
Ingalls Cancer Research Center
Harvey, Illinois, 60426
Mayo Clinic Florida Hematology/Oncology
Jacksonville, Florida, 32224
Integrated Community Oncology Network / Cancer Specialists of North Florida
Jacksonville, Florida, 32256
CCCN
Las Vegas, Nevada, 89169
Suburban Hematology-Oncology Assoc., PC
Lawrenceville, Georgia, 30046
Central Baptist Hospital
Lexington, Kentucky, 40503
Mount Sinai Medical Center
New York, New York, 10029
Christiana Care Health Services
Newark, Delaware, 19713
The Thomas and Dorothy Leavey Cancer Center Northridge Hospital Medical Center
Northridge, California, 91328
Compass Research, LLC
Orange City, Florida, 32763
Oncology Specialists,S.C. Center for Advanced Care
Park Ridge, Illinois, 60068
Illinois CancerCare, P.C.
Peoria, Illinois, 61615
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
Mayo Clinic
Rochester, Minnesota, 55905
Cancer Care Centers of Brevard
Rockledge, Florida, 32955
UC Davis Comprehensive Cancer Center
Sacramento, California
Coborn Cancer Center/ CentraCare Health Plaza
Saint Cloud, Minnesota, 56303
Metro Minnesota CCOP
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Louis Park, Minnesota, 55416
St. John's Hospital
Saint Louis Park, Minnesota, 55416
Sharp Memorial Hospital
San Diego, California, 92123
CPMCRI / Pacific Hematology Oncology Associates
San Francisco, California, 94115
Central Coast Medical Oncology
Santa Maria, California, 93454
UCLA Hematology Oncology
Santa Monica, California, 90404
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101
Suburban Hematology-Oncology Associates, P.C.
Snellville, Georgia, 30078
Hickman Cancer Center at Flower Hospital
Sylvania, Ohio, 43560
H. Lee Moffitt Cancer Center (Moffitt Cancer Center)
Tampa, Florida, 33612
Mercy Cancer Center
Toledo, Ohio, 43623
Carle Cancer Center
Urbana, Illinois, 61801
Georgetown University
Washington D.C., District of Columbia, 20007
Lutheran Hematology & Oncology
Wheat Ridge, Colorado, 80033
Cancer Center of Kansas
Wichita, Kansas, 67208
Cancer Center of Kansas
Wichita, Kansas, 67214
Piedmont Hematology Oncology Associates PA
Winston-Salem, North Carolina, 27103
About this study
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
The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe in the treatment of metastatic, colorectal cancer.
Read the 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
- Being tested
- MORAb-004, Placebo, Best supportive care
- Keywords
- mCRC, chemorefractory metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORAb-004Drug
MORAb-004 8mg per kg IV once a week
PlaceboDrug
Placebo - normal saline IV once a week
Best supportive careOther
Best supportive care to improve quality of life
| Study group | Role | What they receive |
|---|---|---|
| MORAb-004 | Active comparator | Not described Receives: Drug: MORAb-004; Other: Best supportive care |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Other: Best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause. OS was summarized for each treatment group using Kaplan-Meier estimation curves. In the absence of death confirmation or for participants alive at the time of analysis, the survival time was censored at the last date known to be alive.
Measured: 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)
ORR was defined as the percentage of subjects achieving either CR or PR using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: 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)
Time to tumor response was defined for those participants with objective evidence of confirmed CR or PR as the time from randomization to first documentation of objective tumor response (CR or PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: 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)
The DOR was defined as the time from first documentation of objective response (CR or PR) to the first documentation of objective tumor progression or death due to any cause. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: 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
The statistical evidence to support the use of the biomarker identified in Stage 1 interim analysis for Stage 2 selection of participants as designed was not adequate to clearly define a biomarker responsive population. The study was terminated by the sponsor at the end of Stage 1 and enrollment of stage 2 did not occur due to futility, hence Stage 2 and biomarker based analysis for PFS was not carried out.
Measured: From the date of randomization up to approximately 1 year 7 months
Biomarkers Based OS, Within Treatment Group
The statistical evidence to support the use of the biomarker identified in Stage 1 interim analysis for Stage 2 selection of participants as designed was not adequate to clearly define a biomarker responsive population. The study was terminated by the sponsor at the end of Stage 1 and enrollment of stage 2 did not occur due to futility, hence Stage 2 and biomarker based analysis for OS was not carried out.
Measured: From the date of randomization up to approximately 1 year 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study start27 Mar 2012
- Primary completion20 Oct 2013
- Study completion20 Oct 2013
Why it stopped: By the sponsor at the end of Stage 1 due to futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507545
- Sponsor's protocol ID
- MORAb-004-202-CRC
- Status last verified
- Sep 2015
- First submitted
- 5 Dec 2011
- Last updated
- 6 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01507545
- Acronym / sponsor ID
- MORAb-004-202-CRC
- Conditions
- Metastatic Colorectal Cancer, Colorectal Cancer
- Keywords
- mCRC, chemorefractory metastatic colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: By the sponsor at the end of Stage 1 due to futility.
- Enrolment
- 154 participants (actual)
- Lead sponsor
- MorphotekIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2012 (actual)
- Primary completion
- 20 Oct 2013 (actual)
- Study completion
- 20 Oct 2013 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Posted 6 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MORAb-004 | Active comparator | Drug: MORAb-004, Other: Best supportive care |
| Placebo | Placebo comparator | Drug: Placebo, Other: Best supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORAb-004MORAb-004 8mg per kg IV once a week | Drug | MORAb-004 |
| PlaceboPlacebo - normal saline IV once a week | Drug | Placebo |
| Best supportive careBest supportive care to improve quality of life | Other | MORAb-004, Placebo |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 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)
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.
6 secondary outcomes
Overall Survival (OS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: From the date of randomization up to approximately 1 year 7 months
Biomarkers Based OS, Within Treatment Group
Time frame: From the date of randomization up to approximately 1 year 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
67 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MORAb-004 in people with Metastatic Colorectal Cancer and Colorectal Cancer, run by Morphotek at 67 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.