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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: Active Phase 3 study of Neuroendocrine Tumors, sponsored by ITM Solucin.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
PFS determined as time elapsed between randomization, and the date of first objective report of tumor progression (evaluated by RECIST criteria v1.1) as evaluated by the Blinded Independent Central Review (BICR), or death.
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
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2017-02-02 |
| Est. Completion | 2029-11 |
| Phase | Phase 3 |
What the registry record for NCT03049189 still lists
NCT03049189 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, above the 174-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (78% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
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Where NCT03049189's enrollment target sits among peer trials
309 5th of 52 higher than 48 of 52 other Neuroendocrine Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroendocrine Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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