Phase III Double-blinded, Placebo Controlled Study of Xilonix for Improving Survival in Metastatic Colorectal Cancer

Trial Profile

Phase III Double-blinded, Placebo Controlled Study of Xilonix for Improving Survival in Metastatic Colorectal Cancer

Discontinued
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2017

At a glance

  • Drugs MABp1 (Primary) ; Megestrol
  • Indications Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms XCITE
  • Sponsors XBiotech
  • Most Recent Events

    • 12 Jul 2017 This trial has been completed in Belgium (End date:2017-06-29).
    • 09 Jun 2017 According to an XBiotech media release, the IDMC had no safety concerns from the unblinded analysis. However, the committee recommended the early termination of the study since the findings were not sufficient to meet efficacy or the threshold for continuation, which involved a prospectively defined acceptance boundary for the interim analysis of less than or equal to p = 0.08.
    • 09 Jun 2017 Status changed from active, no longer recruiting to discontinued, according to a XBiotech media release.
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