We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02138422
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : March 1, 2021
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Symptomatic Colorectal Cancer Advanced Colorectal Cancer Colorectal Cancer With Cachexia Biological: Xilonix Biological: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : July 31, 2014
Actual Primary Completion Date : November 30, 2015
Actual Study Completion Date : November 30, 2015

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo administered intravenously every 2 weeks
Biological: Placebo
Active Comparator: Xilonix
Xilonix administered intravenously every 2 weeks
Biological: Xilonix

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138422

Layout table for location information
XBiotech Investigative Site
Warsaw, Poland
Sponsors and Collaborators
Janssen Research & Development, LLC
Layout table for investigator information
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02138422    
Other Study ID Numbers: 2014-PT026
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Keywords provided by Janssen Research & Development, LLC:
colorectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Weight Loss
Body Weight Changes
Body Weight