A Study Using MABp1 To Increase Overall Survival In Patients With Colorectal Cancer And Weight Loss
This study is currently recruiting participants.
Verified April 2013 by XBiotech, Inc.
Sponsor:
XBiotech, Inc.
Information provided by (Responsible Party):
XBiotech, Inc.
ClinicalTrials.gov Identifier:
NCT01767857
First received: January 8, 2013
Last updated: April 25, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2014 |
| Estimated Primary Completion Date: | April 2014 (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:
- 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.
- Weight loss of ≥5% over the last 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.
- Palliative radiation and/or chemotherapy are permitted after the initial 2 week washout period.
Exclusion Criteria:
- Mechanical obstruction that would prevent adequate oral nutritional intake.
- Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767857
Contacts
| Contact: Michael Stecher, M.D. | 512-386-2900 |
Locations
| United States, California | |
| Moores UCSD Cancer Center | Recruiting |
| La Jolla, California, United States, 92093 | |
| Contact: Brian Simpson 858-822-7951 besimpson@ucsd.edu | |
| Contact: Bethany Parker, BS,MAS 858 822-5369 bparker@ucsd.edu | |
| Principal Investigator: Eric Roeland, MD | |
| United States, Georgia | |
| Lewis Hall Singletary Oncology Center | Recruiting |
| Thomasville, Georgia, United States, 31792 | |
| Contact: Colette Hilliard, MS,CCRC 229-584-5468 chilliard@archbold.org | |
| Principal Investigator: Teresa Coleman, MD,FACP | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Not yet recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: Aminah Jatoi, M.D. | |
| United States, North Dakota | |
| Mid Dakota Clinic | Recruiting |
| Bismarck, North Dakota, United States, 58501 | |
| Contact: Michelle Dannenfelzer md.legacy@midconetwork.com | |
| Principal Investigator: Vijay Rao, MD | |
| United States, Tennessee | |
| UT Medical Center Cancer Institute | Recruiting |
| Knoxville, Tennessee, United States, 37920 | |
| Contact: Randi R Ray, RN,BSN,OCN 865-305-9773 RRRay@mc.utmck.edu | |
| Principal Investigator: Wahid Hanna, MD | |
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: | April 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by XBiotech, Inc.:
|
Pivotal Cachexia Colorectal Survival Phase 3 |
Additional relevant MeSH terms:
|
Cachexia Colorectal Neoplasms Weight Loss Emaciation Body Weight Changes Body Weight Signs and Symptoms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Megestrol Megestrol Acetate Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Appetite Stimulants |
ClinicalTrials.gov processed this record on May 23, 2013