Telotristat With Lutathera in Neuroendocrine Tumors

Stopped early · Phase 2

Conditions studied: Neuroendocrine Tumors

In brief

This trial will test the hypothesis that Telotristat treatment increases the antitumor efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors (NETs).

Key facts

Study ID

NCT04543955

Run by

Lowell Anthony, MD

People needed

1

Starts

2021-09-13

Expected to finish

2022-06-03

Last updated by the study team

2023-06-27

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Metastatic, or unresectable, histologically confirmed well-differentiated grade 1 and 2 neuroendocrine tumor with a positive gallium 68 Dotatate scan within 6 months prior to study enrollment
• Baseline CT scan or MRI with measurable progressive disease based on RECIST Criteria
• Failure of at least one prior systemic cancer treatment for this diagnosis
• Recovered from Adverse Events of previously administered therapeutic agents to Grade 2 or less toxicity according to CTCAE version 5.0
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• normal organ and marrow function

You may not qualify if…

• Prior exposure to Lutetium Lu 177 Dotatate
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Telotristat or Lutetium Lu 177 Dotatate.
• Presence of unstable angina or myocardial infarction
• New York Heart Association (NYHA) Class III or IV heart failure
• uncontrolled angina
• history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities
• Pregnant or lactating women
• Women of childbearing potential or male patients of reproductive potential
• Any other significant medical or psychiatric condition, currently uncontrolled by treatment, which may interfere with completion of the study

Where it is running

• Markey Cancer Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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