NCT03453489

AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm

Monitoring Telotristat Ethyl Inhibition of Tryptophan Hydroxylase (TPH) in Neuroendocrine Tumors Using ?-[11C]Methyl-L-tryptophan (AMT)-PET

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot trial studies how well telotristat etiprate works in treating participants with well differentiated neuroendocrine neoplasm that has spread to other places in the body and monitored by carbon C 11 alpha-methyltryptophan (AMT)-emission tomography (PET). Telotristat etiprate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying the changes within the tumor cells via AMT-PET may help doctors better understand how tumors respond to treatment with telotristat etiprate.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the effect of telotristat etiprate (telotristat ethyl) treatment in patients with advanced neuroendocrine tumors (NETs) using carbon C 11 alpha-methyltryptophan (alpha-\[11C\]methyl-?L-?tryptophan) (AMT)-?positron emission tomography (PET) as measured by changes in tumor maximum standardized uptake value (SUVmax). SECONDARY OBJECTIVES: I. Show that NETs will have increased AMT uptake on PET, as compared to surrounding non-tumor tissue at baseline. II. Use compartmental modeling (in tumors with the left ventricle of the heart in the field-of-view) to measure change in AMT retention. III. Measure change in AMT retention as mean standardized uptake value (SUVmean). OUTLINE: Participants undergo AMT-PET within 7 days prior to, and 9-14 days after start of telotristat etiprate treatment. Participants receive telotristat etiprate orally (PO) three times a day (TID) for 9-14 days. After completion of study treatment, participants are followed up for 3 months.

Conditions

• Carcinoid Syndrome
• Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm

Interventions

Type	Name	Description
OTHER	Carbon C 11 Alpha-methyltryptophan	Undergo AMT-PET
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Positron Emission Tomography	Undergo AMT-PET
DRUG	Telotristat Etiprate	Given PO

Timeline

• Start date: 2018-06-20
• Primary completion: 2020-10-15
• Completion: 2020-10-15
• First posted: 2018-03-05
• Last updated: 2025-04-10
• Results posted: 2025-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study