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A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer

NCT01767857 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 643

Last updated 2021-06-29

Study results available
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Summary

The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard therapy.

Conditions

Interventions

DRUG

Xilonix

Xilonix is a True Human Monoclonal Antibody targeting Interleukin 1 alpha, and is administered intravenously every 2 weeks with best supportive care until clinical or radiographic progression.

DRUG

Placebo

Placebo plus best supportive care will be administered intravenously every 2 weeks until clinical or radiographic progression.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01767857 on ClinicalTrials.gov