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A Phase 2 Open Label Study to Evaluate the Safety and Effectiveness of 212Pb-DOTAMTATE in Subjects With Somatostatin Receptor Expressing Neuroendocrine Tumors

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A Phase 2 Open Label Study to Evaluate the Safety and Effectiveness of 212Pb-DOTAMTATE in Subjects With Somatostatin Receptor Expressing Neuroendocrine Tumors

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 21 Apr 2025

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At a glance

  • Drugs SAR 447873 (Primary)
  • Indications Gastro-enteropancreatic neuroendocrine tumour; Neuroendocrine tumours
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ALPHAMEDIX02
  • Sponsors RadioMedix

    • Most Recent Events

    • 04 Jun 2024 Results presented at the 60th Annual Meeting of the American Society of Clinical Oncology
    • 12 Feb 2024 According to a RadioMedix media release, the United States FDA has granted Breakthrough Therapy Designation to AlphaMedixTM (212Pb-DOTAMTATE) for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor expressing gastroenteropancreatic neuroendocrine tumors who are naive to peptide receptor radionuclide therapy based on results from phase 1 and the ongoing phase 2 clinical trials that assessed the safety and efficacy of AlphaMedixTM.
    • 17 Oct 2023 Planned number of patients changed from 34 to 68.

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