Actively Recruiting
Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
24
Participants Needed
10
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic or unresectable well- or moderately-differentiated pancreatic neuroendocrine tumors of all grades
- Measurable disease suitable for lutetium Lu 177 dotatate treatment with positive SSR PET/CT and appropriate consultation
- Treatment-naive or up to one prior line of systemic therapy (excluding somatostatin analogs) with documented progression if previously treated
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky score 60% or higher)
- Adequate blood counts and organ function including neutrophils, platelets, bilirubin, liver enzymes, creatinine clearance or GFR, hemoglobin, white blood cells, calcium, and INR
- Cardiac function class 2B or better and left ventricular ejection fraction 50% or higher if history of cardiac disease
- Blood pressure below 140/90 mmHg
- Controlled HIV, hepatitis B or C infections per specified criteria
- Treated and stable brain metastases with no progression and off steroids for at least 1 month
- Prior or concurrent malignancy allowed if it does not interfere with study
- Use of adequate contraception for women of childbearing potential and men; negative pregnancy test required for women
You will not qualify if you...
- Unresolved significant adverse events from prior cancer therapy above grade 1 (except alopecia)
- Receiving other investigational agents
- History of allergic reaction to sunitinib malate or lutetium Lu 177 dotatate
- Need for therapeutic doses of coumarin-derivative anticoagulants (except low doses for thrombosis prophylaxis)
- Conditions preventing swallowing or retention of oral sunitinib
- Serious or non-healing wounds, ulcers, or bone fractures
- Recent abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days
- History of stroke or transient ischemic attack within 12 months
- Recent myocardial infarction, arrhythmia, angina, heart failure, or coronary/peripheral artery procedures within 12 months
- History of pulmonary embolism within 12 months
- Class III or IV heart failure
- Use of strong CYP3A4 inhibitors or inducers before dosing
- Uncontrolled thyroid abnormalities
- Uncontrolled illness
- Pregnant or breastfeeding women
- Prior treatment with sunitinib malate, lutetium Lu 177 dotatate, or other radiopharmaceuticals like MIBG, Y-90, or radioactive iodide
AI-Screening
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Trial Site Locations
Total: 10 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Active, Not Recruiting
2
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
3
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
4
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
5
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
6
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
7
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
9
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
10
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Active, Not Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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