NCT02138422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 31, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2015

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

May 12, 2014

Last Update Submit

February 25, 2021

Conditions

Symptomatic Colorectal CancerAdvanced Colorectal CancerColorectal Cancer With Cachexia

Keywords

colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo administered intravenously every 2 weeks

Biological: Placebo

Xilonix

ACTIVE COMPARATOR

Xilonix administered intravenously every 2 weeks

Biological: Xilonix

Interventions

XilonixBIOLOGICAL
Xilonix
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status 1 or 2.

You may not qualify if:

  • Mechanical obstruction that would prevent adequate oral nutritional intake.
  • \>20% total body weight loss in the previous 6 months.
  • Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy.
  • 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).
  • Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
  • 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.
  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

XBiotech Investigative Site

Warsaw, Poland

Location

Related Publications (2)

  • Hong DS, Hui D, Bruera E, Janku F, Naing A, Falchook GS, Piha-Paul S, Wheler JJ, Fu S, Tsimberidou AM, Stecher M, Mohanty P, Simard J, Kurzrock R. MABp1, a first-in-class true human antibody targeting interleukin-1alpha in refractory cancers: an open-label, phase 1 dose-escalation and expansion study. Lancet Oncol. 2014 May;15(6):656-66. doi: 10.1016/S1470-2045(14)70155-X. Epub 2014 Apr 17.

    PMID: 24746841BACKGROUND

  • Hickish T, Andre T, Wyrwicz L, Saunders M, Sarosiek T, Kocsis J, Nemecek R, Rogowski W, Lesniewski-Kmak K, Petruzelka L, Apte RN, Mohanty P, Stecher M, Simard J, de Gramont A. MABp1 as a novel antibody treatment for advanced colorectal cancer: a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2017 Feb;18(2):192-201. doi: 10.1016/S1470-2045(17)30006-2. Epub 2017 Jan 14.

    PMID: 28094194RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

bermekimab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 14, 2014

Study Start

July 31, 2014

Primary Completion

November 30, 2015

Study Completion

November 30, 2015

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

PL(1)