This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Phase 3 Study to Evaluate Xilonix as an Anticancer Therapy in Patients With Symptomatic Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.
ClinicalTrials.gov Identifier:
NCT02138422
First received: May 12, 2014
Last updated: June 26, 2017
Last verified: June 2017
  Purpose
The primary objective of this study will be to assess how effective Xilonix is in the treatment of patients with symptomatic colorectal cancer. By blocking a substance that helps tumours grow and spread, Xilonix therapy may not only slow tumour growth, but also may improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with colorectal cancer. The effectiveness of the therapy will be measured by assessing the change in these symptoms for patients treated with Xilonix versus those treated with placebo. Reversal of muscle loss will be assessed with a type of X-ray called a DEXA scanner. Improvement in pain, appetite loss, and fatigue will be measured with a questionnaire that is completed by patients enrolled on the trial.

Condition Intervention Phase
Symptomatic Colorectal Cancer Advanced Colorectal Cancer Colorectal Cancer With Cachexia Biological: Xilonix Biological: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Double Blind, Placebo Controlled Pivotal Phase III Study Evaluating Xilonix™ in Symptomatic Colorectal Cancer Patients Refractory to Standard Therapy

Resource links provided by NLM:


Further study details as provided by XBiotech, Inc.:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 8 weeks ]

Estimated Enrollment: 276
Study Start Date: July 2014
Estimated Study Completion Date: August 2017
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo administered intravenously every 2 weeks
Biological: Placebo
Active Comparator: Xilonix
Xilonix administered intravenously every 2 weeks
Biological: Xilonix

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (oxaliplatin may have been in the adjuvant setting) and an irinotecan based regimen.
  2. Symptomatic Disease: One symptom from each domain (metabolic and functional) must be present.

    • Evidence of metabolic dysfunction, defined as the presence of one or more of the following:
    • Any degree (up to 20%) of unintentional total body weight loss in the previous 6 months
    • Serum Interleukin 6 levels ≥10 pg/ml
    • Evidence of reduced function or presence of cancer related symptoms as determined by EORTC QLQ-C30.
    • Appetite reduction, with a score of >10
    • Presence of fatigue, with a score of >10
    • Presence of Pain, with a score of >10
    • Decreased Role, Emotional and Social function, with a score of < 90.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 1 or 2.

Exclusion Criteria:

  1. Mechanical obstruction that would prevent adequate oral nutritional intake.
  2. >20% total body weight loss in the previous 6 months.
  3. Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy.
  4. Uncontrolled or significant cardiovascular disease, including:

    • A myocardial infarction within the past 6 months.
    • Uncontrolled angina within the past 3 months.
    • Congestive heart failure within the past 3 months, if defined as NYHC-II.
    • Diagnosed or suspected congenital long QT syndrome.
    • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes).
    • Any history of second or third degree heart block (may be eligible if currently have a pacemaker).
    • Heart rate < 50 beats per minute on pre-entry electrocardiogram.
    • Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic).
  5. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
  6. Subjects who have not recovered from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1; excluding alopecia and grade 2 neuropathy.
  7. Subjects who have received extensive prior radiation therapy to the bone marrow. Extensive radiation therapy is defined as treatment of more than one axial bony metastasis. However for subjects with rectal cancer pelvic irradiation, in addition to treatment of one axial bony metastasis, is acceptable.
  8. Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV).
  9. Known hepatitis B surface antigen and/or hepatitis C antibody or known history of infection.
  10. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA).
  11. Receipt of a live (attenuated) vaccine within 1 month prior to Randomization
  12. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to Xilonix™ or any component of its formulations.
  13. Women who are pregnant or breastfeeding.
  14. WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to randomization, for the duration of the study, and for at least 3 months after the last dose of study medication.
  15. History of progressive multifocal leukoencephalopathy or other demyelinating disease.
  16. Subjects on immunosuppressive therapy, including transplant patients.
  17. Subjects with known brain metastases. Subjects with symptoms of brain metastases during screening should undergo CT imaging prior to randomization.
  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: NCT02138422

Locations
Poland
XBiotech Investigative Site
Warsaw, Poland
Sponsors and Collaborators
XBiotech, Inc.
Investigators
Study Chair: Tamas Hickish, M.D. Royal Bournemouth Hospital NHS Trust
  More Information

Publications:
Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT02138422     History of Changes
Other Study ID Numbers: 2014-PT026
Study First Received: May 12, 2014
Last Updated: June 26, 2017

Keywords provided by XBiotech, Inc.:
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Cachexia
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2017