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NCT05687123 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
A Phase 1 study of Pancreatic Neoplasm and Metastatic Pancreatic Neuroendocrine Tumor, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 10
- Study locations
NCT05687123: Recruiting Phase 1 study of Pancreatic Neoplasm and Metastatic Pancreatic Neuroendocrine Tumor, sponsored by National Cancer Institute (NCI).
NCT05687123 is a Phase 1 study of Pancreatic Neoplasm and Metastatic Pancreatic Neuroendocrine Tumor that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 658-participant average among 10 other Pancreatic Neoplasm trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05687123, a Phase 1 study of Pancreatic Neoplasm and Metastatic Pancreatic Neuroendocrine Tumor, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 10
- Study locations
Study Summary
This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.
Primary Outcome
Dose-limiting toxicities (DLTs) during the first 8 weeks of the combination of sunitinib malate plus lutetium Lu 177 dotatate and incidence of treatment-emergent AEs during DLT observation period. DLTs will be defined as grade 3 or worse hematologic and non-hematologic toxicity that is considered clinically significant and at least possibly related to lutetium Lu 177 dotatate and sunitinib malate within the first cycle (8 weeks). Safety endpoints will be listed for each dose level and the tabula
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Positron Emission Tomography
- DRUG Lutetium Lu 177 Dotatate
Study Locations (10)
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- Washington University School of Medicine - St Louis
- Siteman Cancer Center-South County - St Louis
- Siteman Cancer Center at Christian Hospital - St Louis
California
- City of Hope Comprehensive Cancer Center - Duarte
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Illinois
- Memorial Hospital East - Shiloh
Ontario
- University Health Network-Princess Margaret Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-08-14 |
| Est. Completion | 2026-12-14 |
| Phase | Phase 1 |
What NCT05687123 shows while recruiting
NCT05687123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 658-participant average among 10 other Pancreatic Neoplasm trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Pancreatic Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05687123 lists 10 locations in 4 states (Missouri, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT05687123 about?
NCT05687123 is a clinical study titled "Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors". This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blo...
What is the current status of trial NCT05687123?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-08-14. Estimated completion is 2026-12-14.
What conditions does trial NCT05687123 study?
This clinical trial studies the following conditions: Pancreatic Neoplasm, Metastatic Pancreatic Neuroendocrine Tumor, Stage III Pancreatic Neuroendocrine Tumor AJCC v8, Stage IV Pancreatic Neuroendocrine Tumor AJCC v8, Unresectable Pancreatic Neuroendocrine Tumor.
What interventions are being tested in trial NCT05687123?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Positron Emission Tomography (PROCEDURE), Lutetium Lu 177 Dotatate (DRUG).
Who is sponsoring clinical trial NCT05687123?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05687123 being conducted?
This trial has 10 study locations across California, Illinois, Missouri, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05687123's enrollment target sits among peer trials
24 8th of 10 higher than 3 of 10 other Pancreatic Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Neoplasm 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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