NCT02592707

Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs

An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical phase I/II study was to investigate the safety and tolerability of satoreotide tetraxetan (177Lu-IPN01072, formerly known as 177Lu-OPS201) used for the treatment of patients with neuroendocrine tumors (NETs). The secondary objectives of this study were the assessment of biodistribution, dosimetry and preliminary efficacy of satoreotide tetraxetan.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Satoreotide tetraxetan	Satoreotide tetraxetan administered in 3 cycles at intervals of 8 weeks (+ up to 2 additional optional cycles)
OTHER	Amino acid solution	Given as an auxiliary product the day of the IMP infusion for safety reasons to protect the renal function. Centres can use their established amino acid infusion or Ipsen amino acid solution (auxiliary medical product OPS301)
OTHER	Antiemetic	To counteract the known side effects of the amino acid infusion, such as nausea, dexamethasone (antiemetic) and as-required ondansetron will be administered 15 to 30 minutes before the start of the amino acid infusion (unless there are contraindications for these drugs).

Timeline

• Start date: 2017-03-06
• Primary completion: 2022-02-22
• Completion: 2022-02-22
• First posted: 2015-10-30
• Last updated: 2023-07-19
• Results posted: 2023-07-19

Locations

9 sites across 8 countries: United States, Australia, Austria, Canada, Denmark, France, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study