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

Phase 3 Terminated 643 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Outcome

Missed primary endpoint

Stopped: “The study crossed the prospective futility boundary of primary endpoint”

registry analysis (superiority test); Xilonix vs Placebo; p = 0.613; Log Rank NCT01767857 ↗

Publications

Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bermekimab	Monoclonal antibody	—	Intravenous