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

Last updated: March 25, 2025
Sponsor: Barbara Ann Karmanos Cancer Institute
Overall Status: Completed

Phase

2

Condition

Digestive System Neoplasms

Neoplasms

Carcinoid Syndrome And Carcinoid Tumours

Treatment

Telotristat Etiprate

Carbon C 11 Alpha-methyltryptophan

Laboratory Biomarker Analysis

Clinical Study ID

NCT03453489
2017-144
P30CA022453
NCI-2018-00294
2017-144
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histopathologically confirmed, well-differentiated metastatic NETs

  • Receiving stable-dose somatostatin analog (long-acting release [LAR], depot) for > 3months before enrollment.

  • Patients with 5-HIAA levels above or below the upper limit of normal range and thosewith unknown values at baseline are allowed to participate.

  • Able to lie within the PET scanner for at least 70 minutes while undergoingscanning.

  • ECOG performance status of 2 or better.

  • Physical exam, CBC and Multiphasic (including electrolytes, BUN, creatinine, totalbilirubin, AST, and ALT) must be done within 28 days of PET imaging and demonstrateadequate renal and liver function. Creatinine ≤ 2.5, total bilirubin ≤ 1.5 x upperlimit 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 isjudged amenable to AMT-PET.

  • Women of child bearing potential must not be pregnant or breastfeeding. A negativeurine or blood pregnancy test must be obtained in women with child bearingpotential. Men and women with reproductive potential must agree to use adequatecontraception (hormonal or barrier method of birth control; abstinence) on studyentry and for the duration of study participation.

  • Eligible and consent signed for imaging with AMT PET under protocol 2011-053.

Exclusion

Exclusion Criteria:

  • Patients experiencing more than 12 watery bowel movements per day associated withvolume contraction, dehydration, or hypotension, or showing evidence of entericinfection 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 receivingcytotoxic chemotherapy (e.g., capecitabine or temozolomide); they cannnot be ontelotristat ethyl; previous use is acceptable if the patient has been off for overone month

Study Design

Total Participants: 4
Treatment Group(s): 4
Primary Treatment: Telotristat Etiprate
Phase: 2
Study Start date:
June 20, 2018
Estimated Completion Date:
October 15, 2020

Study 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.

Connect with a study center

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

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