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NCT03453489 · ClinicalTrials.gov registry record · Phase 2
AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm
A Phase 2 study of Carcinoid Syndrome and Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm, sponsored by Barbara Ann Karmanos Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT03453489: Completed Phase 2 study of Carcinoid Syndrome and Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT03453489 is a Phase 2 study of Carcinoid Syndrome and Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 4 participants, below the 143-participant average among 4 other Carcinoid Syndrome trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03453489, a Phase 2 study of Carcinoid Syndrome and Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Positron Emission Tomography
- OTHER Laboratory Biomarker Analysis
- DRUG Telotristat Etiprate
- OTHER Carbon C 11 Alpha-methyltryptophan
Study Locations (1)
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2020-10-15 |
| Phase | Phase 2 |
What the finished NCT03453489 record still lists
NCT03453489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 143-participant average among 4 other Carcinoid Syndrome trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Carcinoid Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Positron Emission Tomography is the first listed.
NCT03453489 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03453489 about?
NCT03453489 is a clinical study titled "AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm". 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 gr...
What is the current status of trial NCT03453489?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2018-06-20. Estimated completion is 2020-10-15.
What conditions does trial NCT03453489 study?
This clinical trial studies the following conditions: Carcinoid Syndrome, Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm.
What interventions are being tested in trial NCT03453489?
The interventions under investigation include: Positron Emission Tomography (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Telotristat Etiprate (DRUG), Carbon C 11 Alpha-methyltryptophan (OTHER).
Who is sponsoring clinical trial NCT03453489?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03453489 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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