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
  Purpose

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.


Condition Intervention Phase
Metastatic Colorectal Cancer
Cachexia
Weight Loss
Drug: MABp1
Drug: Megestrol Acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pivotal Phase III Study to Evaluate Overall Survival Using MABp1 as a Monotherapy in Metastatic Colorectal Cancer Patients With Cachexia

Resource links provided by NLM:


Further study details as provided by XBiotech, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 656
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MABp1
MABp1 administered IV every two weeks, plus best supportive care
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
Active Comparator: megestrol acetate
megestrol acetate administered daily plus best supportive care.
Drug: Megestrol Acetate
megestrol acetate oral suspension will be administered daily for as long as the patient is benefiting clinically.
Other Name: Megace

  Eligibility

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

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.
  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: NCT01767857

  Show 32 Study Locations
Sponsors and Collaborators
XBiotech, Inc.
Investigators
Study Chair: Aminah Jatoi, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT01767857     History of Changes
Other Study ID Numbers: 2012-PT023
Study First Received: January 8, 2013
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by XBiotech, Inc.:
Pivotal
Cachexia
Colorectal
Survival
Phase 3

Additional relevant MeSH terms:
Colorectal Neoplasms
Weight Loss
Cachexia
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Emaciation
Megestrol
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants

ClinicalTrials.gov processed this record on October 19, 2014