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

Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 27 Jul 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

    • 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.
    • 27 Jul 2017 According to an Advanced Accelerator Applications media release, the FDA allowed an amendment to the protocol for the US Expanded Access Program (EAP) for lutetium Lu 177 dotatate (Lutathera) 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.
    • 09 Jan 2017 According to an Advanced Accelerator Applications media release, an additional sites are expected to enroll in 2017.
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