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NCT03049189 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Neuroendocrine Tumors, sponsored by ITM Solucin.

Active
Registry status
Phase 3
Development phase
309
Enrollment target
20
Study locations

NCT03049189 is a Phase 3 study of Neuroendocrine Tumors that is active but no longer recruiting, run by ITM Solucin. The registered enrollment target is 309 participants, above the 174-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (78% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT03049189, a Phase 3 study of Neuroendocrine Tumors, is active but no longer recruiting, sponsored by ITM Solucin.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
309 participants
Enrollment target
20
Study locations

Study 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 Studied

Interventions

  • DRUG Everolimus
  • OTHER Amino-Acid Solution
  • DRUG 177Lu-edotreotide PRRT

Study Locations (20)

Other

  • Allgemeines Krankenhaus Wien - Vienna
  • Institut Jules Bordet - Brussels
  • Universitaire Ziekenhuizen Leuven - Leuven
  • University Hospital Olomouc - Olomouc
  • University Hospital Motol - Prague
  • Hospices civils de Lyon - Bron
  • Centre Jean Perrin - Clermont-Ferrand
  • HP Hôpital Beaujon - Clichy
  • Institut de Recherche en Cancérologie de Montpellier (IRCM) - Montpellier
  • CHU de Nantes - Hôtel Dieu - Nantes

Victoria

  • Olivia Newton-John Cancer & Wellness Centre, Austin Hospital - Heidelberg
  • Peter MacCallum Cancer Centre - Melbourne

Arizona

  • Banner Health d.b.a. Banner MD Anderson Cancer Center - Gilbert

California

  • Stanford University - Stanford

Florida

  • Moffitt Cancer Center & Research Institute - Tampa

Illinois

  • Northwestern Memorial Hospital - Chicago

Michigan

  • University of Michigan Comprehensive Cancer Center - Ann Arbor

Texas

  • Excel Diagnostics & Nuclear Oncology Center - Houston

Trial Details

FieldValue
Enrollment Target 309 participants
Start Date 2017-02-02
Est. Completion 2029-11
Phase Phase 3

Sponsor

ITM Solucin

3 total trials

What the Registry Record Tells You About NCT03049189

The ClinicalTrials.gov registry entry for NCT03049189 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 174-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (78% higher). The listed sponsor is ITM Solucin, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 3 interventions - of which Everolimus is the first listed.

NCT03049189 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Victoria, Arizona.

Frequently Asked Questions

What is clinical trial NCT03049189 about?

NCT03049189 is a clinical study titled "Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients". 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 gastro...

What is the current status of trial NCT03049189?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2017-02-02. Estimated completion is 2029-11.

What conditions does trial NCT03049189 study?

This clinical trial studies the following conditions: Neuroendocrine Tumors.

What interventions are being tested in trial NCT03049189?

The interventions under investigation include: Everolimus (DRUG), Amino-Acid Solution (OTHER), 177Lu-edotreotide PRRT (DRUG).

Who is sponsoring clinical trial NCT03049189?

This trial is sponsored by ITM Solucin, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03049189 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.