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

Conditions

• Metastatic Pancreatic Neuroendocrine Tumor
• Pancreatic Neoplasm
• Stage III Pancreatic Neuroendocrine Tumor AJCC v8
• Stage IV Pancreatic Neuroendocrine Tumor AJCC v8
• Unresectable Pancreatic Neuroendocrine Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo a blood sample collection
• Computed Tomography — PROCEDURE
  Undergo a CT scan
• Lutetium Lu 177 Dotatate — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo a SSR PET/CT scan
• Sunitinib Malate — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Aug 14, 2024

Status verified

Apr 2026

Primary completion

Dec 14, 2026

Completion

Dec 14, 2026

Study Design

Enrollment

24 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (sunitinib malate, lutetium Lu 177 dotatate)
  Patients receive sunitinib malate PO QD from day 1 of lutetium 177 dotatate therapy to 28 days after the last dose of lutetium 177 dotatate in the absence of unacceptable toxicity. Patients also receive lutetium Lu 177 dotatate IV over 30 minutes on day 1 of each cycle. Cycles repeat Q8W for 4 cycles in the absence of unacceptable toxicity. Patients undergo a CT scan and/or MRI throughout the trial. Patients also undergo a SSR PET/CT scan during screening and blood sample collection on study.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Within the first cycle (8 weeks) ]

Locations (9)

Find similar trials in Duarte, CA

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