Telotristat With Lutathera in Neuroendocrine Tumors

  • STATUS
    Recruiting
  • End date
    Jun 30, 2034
  • participants needed
    70
  • sponsor
    Aman Chauhan
Updated on 10 October 2021

Summary

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

Description

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.

Details
Condition neuroendocrine tumors, neuroendocrine tumour, Neuroectodermal Tumor, Neurectoderma, Neuroendocrine Tumor
Treatment Telotristat (Low-Dose), Telotristat (High-Dose)
Clinical Study IdentifierNCT04543955
SponsorAman Chauhan
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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
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