Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable, Somatostatin Receptor Positive, Neuroendocrine Tumors, Progressive Under Somatostatin Analogue Therapy

Trial Profile

Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable, Somatostatin Receptor Positive, Neuroendocrine Tumors, Progressive Under Somatostatin Analogue Therapy

Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Octreotate-Lu-177-DOTA-Tyr-3 (Primary)
  • Indications Carcinoid tumour; Neuroendocrine tumours
  • Focus Expanded access; Therapeutic Use
  • Sponsors Advanced Accelerator Applications
  • Most Recent Events

    • 17 Nov 2017 According to an Advanced Accelerator Applications media release, in an Expanded Access program, 226 patients were participating from 30 centers in USA.
    • 31 Aug 2017 According to an Advanced Accelerator Applications media release, an Expanded Accss program in USA were participating 140 patients from 23 centres at 31 July 2017.
    • 27 Jul 2017 According to an Advanced Accelerator Applications media release, the protocol has been amended to permit enrollment of patients with metastasized or locally advanced, inoperable neuroendocrine tumors (NETs) arising at all sites (including foregut, midgut and hindgut), and that have progressive disease during or after treatment with somatostatin analogues. In addition, the amendment includes the use of a 2.5% lysine/arginine amino acid solution as an additional option for renal protection.
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