Telotristat With Lutathera in Neuroendocrine Tumors
Telotristat With Lutathera in Neuroendocrine Tumors
This trial will test the hypothesis that Telotristat treatment increases the antitumor
 efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors (NETs).
Neuroendocrine tumors (NETs) are a very heterogeneous group of tumors that develop
 predominantly in the gastrointestinal and pulmonary systems. Clinical detection and diagnosis
 are more reliable at late stages when metastatic spread has occurred. Patients with advanced
 disease may suffer from complications of uncontrolled hormone secretion and usually succumb
 due to tumor progression.

 This trial tests the hypothesis that inhibition of serotonin production with Telotristat will
 lead to cytostatic effects on neuroendocrine tumors and will complement the anti-tumor
 activity of Lutetium 177 Dotatate. The proposed combination may result in improved treatment
 efficacy as reflected by improved 20-month progression-free survival (PFS) as compared to
 historical control.
Inclusion Criteria:

 -  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 AEs of previously administered therapeutic agents to Grade 2 or less
 toxicity according to CTCAE version 5.0

 -  ECOG performance status ≤2

 -  normal organ and marrow function

 Exclusion Criteria:

 -  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

 -  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