NCT03453489|CompletedPhase 2ResultsDMCFDA Drug
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Monitoring Telotristat Ethyl Inhibition of Tryptophan Hydroxylase (TPH) in Neuroendocrine Tumors Using ?-[11C]Methyl-L-tryptophan (AMT)-PET
Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
OTHER · Wayne State University/Karmanos Cancer Institute
NIH
OTHER · Lexicon
interventional
4
1 country
1
Study Start
June 20, 2018
Actual (reported)Primary Completion
October 15, 2020
Actual (reported)Study Completion
October 15, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 27, 2018
Actual (reported)March 5, 2018
Actual (reported)June 20, 2018
Actual (reported)October 15, 2020
Actual (reported)October 15, 2020
Actual (reported)April 10, 2025
Actual (reported)The Proportion of Patients Who Achieved SUVmax Reduction of 20% or More Between Baseline and Follow up Scan
The proportion of patients who achieved maximum standardized uptake value (SUVmax) reduction of 20% or more between baseline and follow up scan. It will be reported with a one-sided, 90% confidence limit.
Baseline up to follow up, assessed up to 3 months
Change in Mean Standardized Uptake Value (SUVmean)
Baseline up to 3 months
Neuroendocrine Tumors Visibility
At baseline
Difference in SUVmax of AMT Uptake Between the Tumor Mass and Background at Baseline
Baseline
Participants undergo AMT-PET within 7 days prior to, and 9-14 days after start of telotristat etiprate treatment. Participants receive telotristat etiprate PO TID for 9-14 days.
Undergo AMT-PET
Correlative studies
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Anthony Shields
Barbara Ann Karmanos Cancer Institute
4 participants (actual enrollment reported by the registry).
First Submitted
February 27, 2018
First Posted
March 5, 2018
Study Start
June 20, 2018
Actual (reported)Undergo AMT-PET
Given PO
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 15, 2020
Actual (reported)Study Completion
October 15, 2020
Actual (reported)Last Updated
April 10, 2025
Results First Posted
April 10, 2025
Record last verified: 2025-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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