RecruitingPhase 1NCT05687123

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

A Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine Tumors


Sponsor

National Cancer Institute (NCI)

Enrollment

24 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding sunitinib (a targeted therapy pill) to lutetium-177 dotatate (a radioactive treatment) improves outcomes in people with pancreatic neuroendocrine tumors (a specific type of pancreatic cancer) that have spread and cannot be surgically removed. **You may be eligible if...** - You are 18 or older - You have confirmed metastatic or unresectable pancreatic neuroendocrine tumors (PNETs) - Your tumor takes up the radioactive tracer on a special scan (SSR PET/CT), meaning it is eligible for lutetium-177 dotatate treatment - Your cancer has progressed in the last 12 months - You have had no more than one prior systemic therapy (somatostatin analogs don't count) - Your blood counts, kidney, and liver function meet minimum thresholds **You may NOT be eligible if...** - Your tumor does not take up the radioactive tracer on the required scan - You are pregnant or breastfeeding - Your kidney or liver function is significantly impaired - You have had more than one prior line of non-somatostatin systemic therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo a blood sample collection

PROCEDUREComputed Tomography

Undergo a CT scan

DRUGLutetium Lu 177 Dotatate

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo a SSR PET/CT scan

DRUGSunitinib Malate

Given PO


Locations(10)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Memorial Hospital East

Shiloh, Illinois, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05687123


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