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

NCT03453489 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2017-144NCI-2018-00294P30CA022453
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoid Syndrome; Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Other: Carbon C 11 Alpha-methyltryptophan; Other: Laboratory Biomarker Analysis; Procedure: Positron Emission Tomography; Drug: Telotristat Etiprate

Interventions

Carbon C 11 Alpha-methyltryptophan OTHER

Undergo AMT-PET

Also known as: 11C-alpha-methyltryptophan, 11C-AMT, [11C] AMT, alpha-[11C]methyl-L-tryptophan

Treatment (AMT-PET, telotristat etiprate)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (AMT-PET, telotristat etiprate)

Positron Emission Tomography PROCEDURE

Undergo AMT-PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Treatment (AMT-PET, telotristat etiprate)

Telotristat Etiprate DRUG

Given PO

Also known as: LX1032 Hippurate, LX1606, LX1606 Hippurate, TPH Inhibitor LX1606, Tryptophan Hydroxylase Inhibitor LX1032, Tryptophan Hydroxylase Inhibitor LX1606

Treatment (AMT-PET, telotristat etiprate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Serotonin Syndrome

Interventions

alpha-methyltryptophan; Magnetic Resonance Spectroscopy; telotristat; telotristat ethyl

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Anthony F. Shields, MD, PhD
• Organization: Barbara Ann Karmanos Cancer Institute

shieldsa@karmanos.org

313-576-8735

Study Officials

• Anthony Shields

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: June 20, 2018
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Locations

US (1)