Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)
The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe in the treatment of metastatic, colorectal cancer.
Metastatic Colorectal Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Progression-free survival [ Time Frame: 16 wks after last patient enrolled ] [ Designated as safety issue: No ]after 107 subjects have experienced disease progression or died prior to exhibiting disease progression
- Timeframe between first treatment until death for all subjects [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]Overall survival will be measured from first treatment until time to event (death).
- Number of subjects with adverse events [ Time Frame: 20 Months ] [ Designated as safety issue: Yes ]Safety and tolerability will be measured by number of adverse events, ECG results, vital sign assessments, and review of laboratory tests.
- Quality of Life [ Time Frame: 20 Months ] [ Designated as safety issue: Yes ]Quality of Life will be measured by reviewing responses on questionaaires about how the subject is feeling.
- Overall response rate based on RECIST criteria [ Time Frame: 20 Months ] [ Designated as safety issue: Yes ]Overall response rate will be measured by the investigator's assessment of how the subject is responding to the study treatment in regards to the RECISIT criteria.
|Study Start Date:||March 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: MORAb-004||
MORAb-004 8mg IV per kg once a week
|Placebo Comparator: Placebo||
Placebo - normal saline IV once a week
Colorectal cancer is the third most common new cancer diagnosis by 2011 estimates and, by far, the most common digestive system cancer. The number of anticipated new cases in 2011 in the US is 141,210, being equally distributed between men and women. 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 which binds to TEM-1 may be efficacious in the treatment of metastatic, colorectal cancer. This clinical trial 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507545
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|Study Director:||John Heyburn||Morphotek, Inc.|