A multi-centre, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumours

Trial Profile

A multi-centre, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumours

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Jul 2017

At a glance

  • Drugs Octreotate-Lu-177-DOTA-Tyr-3 (Primary) ; Amino acids; Octreotide
  • Indications Carcinoid tumour; Neuroendocrine tumours
  • Focus Registrational; Therapeutic Use
  • Acronyms NETTER-1
  • Sponsors Advanced Accelerator Applications
  • Most Recent Events

    • 27 Jul 2017 According to an Advanced Accelerator Applications media release, the company has resubmitted the New Drug Application for Lutathera to the US Food and Drug Administration. The company has resubmitted the NDA following receipt of a complete response letter from the FDA in December 2016, in which the Agency cited issues with the format, traceability, uniformity, and completeness relating to the NETTER-1 and Erasmus clinical datasets.
    • 21 Jul 2017 According to an Advanced Accelerator Applications media release, the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending the marketing authorization of lutetium (177Lu) oxodotreotide (Lutathera) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
    • 10 Jun 2017 Biomarkers information updated
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