An open-label, multi-center, phase 2 safety and efficacy study of denosumab (AMG 162) in subjects with recurrent or unresectable giant cell tumor (GCT) of bone.

Trial Profile

An open-label, multi-center, phase 2 safety and efficacy study of denosumab (AMG 162) in subjects with recurrent or unresectable giant cell tumor (GCT) of bone.

Completed
Phase of Trial: Phase II

Latest Information Update: 03 Jun 2015

At a glance

  • Drugs Denosumab (Primary)
  • Indications Bone cancer; Giant cell tumours
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen
  • Most Recent Events

    • 13 Jun 2013 Denosumab has been approved in a new indication by the US FDA, based on the positive results of this and another phase II trial (see profile 700034364), according to an Amgen media release.
    • 11 May 2011 Actual end date (Feb 2011) added as reported by ClinicalTrials.gov.
    • 11 May 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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