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An Open-Label, Multi-Center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Trial Profile

An Open-Label, Multi-Center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Dec 2021

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At a glance

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

    • 18 Dec 2021 This trial has been completed in Italy, according to European Clinical Trials Database record.(17 May 2018)
    • 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.
    • 05 Nov 2019 Results published in the Lancet Oncology.
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