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Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

NCT03049189 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2026-04-06

Study results available
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Summary

The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

Conditions

Interventions

DRUG

177Lu-edotreotide PRRT

PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.

DRUG

Everolimus

Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.

OTHER

Amino-Acid Solution

The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT

Sponsors & Collaborators

  • ABX CRO

    collaborator OTHER

  • PSI CRO

    collaborator INDUSTRY

  • ITM Solucin GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2024-11-27
Completion
2029-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • South Africa
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03049189 on ClinicalTrials.gov