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Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01507545
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : September 21, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Colorectal Cancer Drug: MORAb-004 Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: MORAb-004 Drug: MORAb-004
MORAb-004 8mg IV per kg once a week

Placebo Comparator: Placebo Drug: Placebo
Placebo - normal saline IV once a week

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 16 wks after last patient enrolled ]
    after 107 subjects have experienced disease progression or died prior to exhibiting disease progression

Secondary Outcome Measures :
  1. Timeframe between first treatment until death for all subjects [ Time Frame: 20 months ]
    Overall survival will be measured from first treatment until time to event (death).

  2. Number of subjects with adverse events [ Time Frame: 20 Months ]
    Safety and tolerability will be measured by number of adverse events, ECG results, vital sign assessments, and review of laboratory tests.

  3. Quality of Life [ Time Frame: 20 Months ]
    Quality of Life will be measured by reviewing responses on questionaaires about how the subject is feeling.

  4. Overall response rate based on RECIST criteria [ Time Frame: 20 Months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01507545

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Sponsors and Collaborators
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Study Director: John Heyburn Morphotek

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Responsible Party: Morphotek Identifier: NCT01507545     History of Changes
Other Study ID Numbers: MORAb-004-202-CRC
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: September 21, 2015
Last Verified: September 2015
Keywords provided by Morphotek:
chemorefractory metastatic colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases