Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors

NCT05687123 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 24 participants
Start Date 2024-08-14
Est. Completion 2026-12-14
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05687123

The ClinicalTrials.gov registry entry for NCT05687123 describes a study currently listed as recruiting. It is categorized as Phase 1, 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 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT05687123 reports 10 study locations spanning 4 distinct geographic areas — top geographies include Missouri, California, Illinois. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05687123?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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