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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: Active Phase 3 study of Neuroendocrine Tumors, sponsored by ITM Solucin.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS (Progression-Free Survival), defined as the time from randomization until documented RECIST v1.1 (Response evaluation criteria in solid tumors) progression or death, whichever occurs first.
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 |
What the registry record for NCT04919226 still lists
NCT04919226 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, above the 175-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (48% higher).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
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Where NCT04919226's enrollment target sits among peer trials
259 9th of 52 higher than 44 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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