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
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Colorectal Cancer
Drug: MORAb-004
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 126
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507545

  Show 67 Study Locations
Sponsors and Collaborators
Morphotek
Investigators
Study Director: John Heyburn Morphotek, Inc.
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01507545     History of Changes
Other Study ID Numbers: MORAb-004-202-CRC
Study First Received: December 5, 2011
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Morphotek:
mCRC
chemorefractory metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 22, 2014