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NCT04919226 · ClinicalTrials.gov registry record · Phase 3
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
A Phase 3 study of Neuroendocrine Tumors, sponsored by ITM Solucin.
- Active
- Registry status
- Phase 3
- Development phase
- 259
- Enrollment target
- 20
- Study locations
NCT04919226 is a Phase 3 study of Neuroendocrine Tumors that is active but no longer recruiting, run by ITM Solucin. The registered enrollment target is 259 participants, above the 175-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (48% higher). The trial reports 20 study locations across 17 states.
The verdict
NCT04919226, 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
- 259 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
- DRUG CAPTEM (Capecitabine and Temozolomide)
- OTHER Amino-Acid Solution
- DRUG FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Study Locations (20)
New York
- Memorial Sloan-Kettering Cancer Center - New York
- ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute - New York
Texas
- Texas Oncology - Dallas
- University of Texas MD Anderson Cancer Center - Houston
Other
- Fudan University Shanghai Cancer Center - Shanghai
- Affiliated Hospital of Jiangnan University - Wuxi
California
- Stanford Cancer Center - Palo Alto
Colorado
- University of Colorado Hospital, Nuclear Medicine - Aurora
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Massachusetts
- Dana Farber Cancer Institute - Boston
Minnesota
- Mayo Clinic - Rochester, Department of Oncology - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2021-12-21 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04919226
The ClinicalTrials.gov registry entry for NCT04919226 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 175-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (48% 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 5 interventions - of which Everolimus is the first listed.
NCT04919226 reports 20 study locations spanning 17 distinct geographic areas - top geographies include New York, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT04919226 about?
NCT04919226 is a clinical study titled "Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE". The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, soma...
What is the current status of trial NCT04919226?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 259 participants. The study started on 2021-12-21. Estimated completion is 2027-09.
What conditions does trial NCT04919226 study?
This clinical trial studies the following conditions: Neuroendocrine Tumors.
What interventions are being tested in trial NCT04919226?
The interventions under investigation include: Everolimus (DRUG), 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT (DRUG), CAPTEM (Capecitabine and Temozolomide) (DRUG), Amino-Acid Solution (OTHER), FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) (DRUG).
Who is sponsoring clinical trial NCT04919226?
This trial is sponsored by ITM Solucin, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04919226 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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