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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.

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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.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Apr 2022

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At a glance

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

    • Most Recent Events

    • 30 Jun 2020 According to a BeiGene media release, the Amgen gained approval from the China National Medical Products Administration (NMPA) for XGEVA in May 2019 for the treatment of adults and skeletally mature adolescents (defined by at least one mature long bone and with a body weight = 45 kg) with GCTB that is unresectable or where surgical resection is likely to result in severe morbidity, based on the data from this and NCT00680992.
    • 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.

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