Carcinoid SyndromePhase 2NCT03453489
AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm
A Phase 2 study testing Carbon C 11 Alpha-methyltryptophan, Laboratory Biomarker Analysis and Positron Emission Tomography in people with Carcinoid Syndrome and Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Syndrome, Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm
- What is being tested?
- Carbon C 11 Alpha-methyltryptophan, Laboratory Biomarker Analysis and Positron Emission Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 15 Oct 2020
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed, well-differentiated metastatic NETs
- Receiving stable-dose somatostatin analog (long-acting release [LAR], depot) for > 3 months before enrollment.
- Patients with 5-HIAA levels above or below the upper limit of normal range and those with unknown values at baseline are allowed to participate.
- Able to lie within the PET scanner for at least 70 minutes while undergoing scanning.
- ECOG performance status of 2 or better.
- Physical exam, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST, and ALT) must be done within 28 days of PET imaging and demonstrate adequate renal and liver function. Creatinine ≤ 2.5, total bilirubin ≤ 1.5 x upper limit of normal (ULN). AST and ALT ≤ 2.5 ULN.
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- Patient must have a least one lesion greater than 2 cm on standard imaging (CT, MR, octreotide, or dotatate imaging within 8 weeks of the start of the study) that is judged amenable to AMT-PET.
- Women of child bearing potential must not be pregnant or breastfeeding. A negative urine or blood pregnancy test must be obtained in women with child bearing potential. Men and women with reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) on study entry and for the duration of study participation.
- Eligible and consent signed for imaging with AMT PET under protocol 2011-053.
Who cannot join
- Patients experiencing more than 12 watery bowel movements per day associated with volume contraction, dehydration, or hypotension, or showing evidence of enteric infection are excluded
- Patients are excluded if they had undergone tumor-directed therapy within 3 months
- Patients cannot be on a targeted agent (e.g., sunitinib or everolimus) or receiving cytotoxic chemotherapy (e.g., capecitabine or temozolomide); they cannnot be on telotristat ethyl; previous use is acceptable if the patient has been off for over one month
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: Monitoring Telotristat Ethyl Inhibition of Tryptophan Hydroxylase (TPH) in Neuroendocrine Tumors Using ?-[11C]Methyl-L-tryptophan (AMT)-PET
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Carbon C 11 Alpha-methyltryptophan, Laboratory Biomarker Analysis, Positron Emission Tomography, Telotristat Etiprate
- Medical subject headings
- Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon C 11 Alpha-methyltryptophanOther
Also called 11C-alpha-methyltryptophan, 11C-AMT, [11C] AMT, alpha-[11C]methyl-L-tryptophan
Undergo AMT-PET
Laboratory Biomarker AnalysisOther
Correlative studies
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo AMT-PET
Telotristat EtiprateDrug
Also called LX1032 Hippurate, LX1606, LX1606 Hippurate, TPH Inhibitor LX1606
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (AMT-PET, telotristat etiprate) | Experimental | 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. Receives: Other: Carbon C 11 Alpha-methyltryptophan; Other: Laboratory Biomarker Analysis; Procedure: Positron Emission Tomography; Drug: Telotristat Etiprate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to follow up, assessed up to 3 months
Secondary outcomes (3)
Change in Mean Standardized Uptake Value (SUVmean)
Will be reported as percent change with two-sided 95% confidence intervals. Paired t test will be used for pre-and post-treatment SUVs if normality assumption holds.
Measured: Baseline up to 3 months
Neuroendocrine Tumors Visibility
Proportion of patients with visible neuroendocrine tumors at baseline out of total number of patients. The outcome will be reported as proportion and 95% CI
Measured: At baseline
Difference in SUVmax of AMT Uptake Between the Tumor Mass and Background at Baseline
Difference will be reported as percent of (SUVmax.tumor - SUVmax.background)/SUVmax.background in the baseline scan with 95% Confidence Interval
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start20 Jun 2018
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoid SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Anthony F. Shields, MD PhD, Barbara Ann Karmanos Cancer Institute
- Investigators
- Anthony Shields, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453489
- Sponsor's protocol ID
- 2017-144
- Other IDs
- NCI-2018-00294, 2017-144, P30CA022453, 2017-144
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2018
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No