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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-20

Study Completion Date

2020-10-15

Brief Summary

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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.

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Detailed Description

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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

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Carcinoid Syndrome Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (AMT-PET, telotristat etiprate)

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.

Group Type EXPERIMENTAL

Carbon C 11 Alpha-methyltryptophan

Intervention Type OTHER

Undergo AMT-PET

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo AMT-PET

Telotristat Etiprate

Intervention Type DRUG

Given PO

Interventions

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Carbon C 11 Alpha-methyltryptophan

Undergo AMT-PET

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Positron Emission Tomography

Undergo AMT-PET

Intervention Type PROCEDURE

Telotristat Etiprate

Given PO

Intervention Type DRUG

Other Intervention Names

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11C-alpha-methyltryptophan 11C-AMT [11C] AMT alpha-[11C]methyl-L-tryptophan Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging LX1032 Hippurate LX1606 LX1606 Hippurate TPH Inhibitor LX1606 Tryptophan Hydroxylase Inhibitor LX1032 Tryptophan Hydroxylase Inhibitor LX1606

Eligibility Criteria

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Inclusion Criteria

* 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.
* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No