Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
- Conditions
- Colorectal CancerMetastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT01507545
- Lead Sponsor
- Morphotek
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 154
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Placebo Best supportive care - MORAb-004 MORAb-004 - MORAb-004 Best supportive care -
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) 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.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From the date of randomization to the date of death due to any cause (up to approximately 1 year 7 months) 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.
Biomarkers Based OS, Within Treatment Group From the date of randomization up to approximately 1 year 7 months 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.
Overall Response Rate (ORR) From the date of randomization to the first documentation of CR or PR (up to approximately 1 year 7 months) 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.
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) 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.
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) 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.
Biomarkers Based PFS, Within Treatment Group From the date of randomization up to approximately 1 year 7 months 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.
Trial Locations
- Locations (65)
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
Scroll for more (55 remaining)Central Hem/Onc Medical Group, Inc.🇺🇸Alhambra, California, United States