A Study Using MABp1 To Increase Overall Survival In Patients With Colorectal Cancer And Weight Loss

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.
ClinicalTrials.gov Identifier:
NCT01767857
First received: January 8, 2013
Last updated: August 7, 2014
Last verified: August 2014

January 8, 2013
August 7, 2014
March 2013
August 2016   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: baseline to 18 months ] [ Designated as safety issue: No ]
The difference in median overall survival will be compared between the two arms.
Same as current
Complete list of historical versions of study NCT01767857 on ClinicalTrials.gov Archive Site
  • Change in Lean Body Tissue [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Quality of life questionnaire [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Using MABp1 To Increase Overall Survival In Patients With Colorectal Cancer And Weight Loss
A Pivotal Phase III Study to Evaluate Overall Survival Using MABp1 as a Monotherapy in Metastatic Colorectal Cancer Patients With Cachexia

The purpose of this study is to determine if the True Human Monoclonal antibody MABp1 can prolong the life of colorectal carcinoma patients who are losing weight.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Colorectal Cancer
  • Cachexia
  • Weight Loss
  • Drug: MABp1
    MABp1 is a True Human Monoclonal Antibody targeting Interleukin 1 alpha, and is administered intravenously every 2 weeks for as long as the patient is benefiting clinically.
    Other Name: Xilonix
  • Drug: Megestrol Acetate
    megestrol acetate oral suspension will be administered daily for as long as the patient is benefiting clinically.
    Other Name: Megace
  • Experimental: MABp1
    MABp1 administered IV every two weeks, plus best supportive care
    Intervention: Drug: MABp1
  • Active Comparator: megestrol acetate
    megestrol acetate administered daily plus best supportive care.
    Intervention: Drug: Megestrol Acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
656
December 2016
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have failed both an oxaliplatin and an irinotecan based regimen.
  2. Weight loss of ≥5% over the last 6 months.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.
  4. Palliative radiation and/or chemotherapy are permitted after the initial 2 week washout period.

Exclusion Criteria:

  1. Mechanical obstruction that would prevent adequate oral nutritional intake.
  2. Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01767857
2012-PT023
No
XBiotech, Inc.
XBiotech, Inc.
Not Provided
Study Chair: Aminah Jatoi, M.D. Mayo Clinic
XBiotech, Inc.
August 2014

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