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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01507545
First received: December 5, 2011
Last updated: May 5, 2014
Last verified: May 2014

December 5, 2011
May 5, 2014
March 2012
October 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01507545 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe in the treatment of metastatic, colorectal cancer.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Metastatic Colorectal Cancer
  • Colorectal Cancer
  • Drug: MORAb-004
    MORAb-004 8mg IV per kg once a week
  • Drug: Placebo
    Placebo - normal saline IV once a week
  • Active Comparator: MORAb-004
    Intervention: Drug: MORAb-004
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
December 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01507545
MORAb-004-202-CRC
Yes
Morphotek
Morphotek
Not Provided
Study Director: John Heyburn Morphotek, Inc.
Morphotek
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP