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ACTIVE NOT RECRUITING Phase 3

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

NCT03049189 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03049189

The ClinicalTrials.gov registry entry for NCT03049189 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ITM Solucin, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03049189 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Victoria, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03049189?

The interventions under investigation include: Everolimus (DRUG), Amino-Acid Solution (OTHER), 177Lu-edotreotide PRRT (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03049189?

This trial is sponsored by ITM Solucin, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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