Trial Outcomes & Findings for AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm (NCT NCT03453489)

Last Updated: 2025-04-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Baseline up to follow up, assessed up to 3 months

Results posted on

2025-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	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. Carbon C 11 Alpha-methyltryptophan: Undergo AMT-PET Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo AMT-PET Telotristat Etiprate: Given PO
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (AMT-PET, Telotristat Etiprate) n=4 Participants 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. Carbon C 11 Alpha-methyltryptophan: Undergo AMT-PET Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo AMT-PET Telotristat Etiprate: Given PO
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to follow up, assessed up to 3 months

Outcome measures

Outcome measures
Measure	Treatment (AMT-PET, Telotristat Etiprate) n=4 Participants 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. Carbon C 11 Alpha-methyltryptophan: Undergo AMT-PET Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo AMT-PET Telotristat Etiprate: Given PO
The Proportion of Patients Who Achieved SUVmax Reduction of 20% or More Between Baseline and Follow up Scan	0 Proportion of participants Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Baseline up to 3 months

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.

Outcome measures

Outcome measures
Measure	Treatment (AMT-PET, Telotristat Etiprate) n=4 Participants 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. Carbon C 11 Alpha-methyltryptophan: Undergo AMT-PET Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo AMT-PET Telotristat Etiprate: Given PO
Change in Mean Standardized Uptake Value (SUVmean)	46.01 Percentage change Interval -56.06 to 148.08

SECONDARY outcome

Timeframe: At baseline

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

Outcome measures

Outcome measures
Measure	Treatment (AMT-PET, Telotristat Etiprate) n=4 Participants 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. Carbon C 11 Alpha-methyltryptophan: Undergo AMT-PET Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo AMT-PET Telotristat Etiprate: Given PO
Neuroendocrine Tumors Visibility	1 Proportion of participants Interval 0.51 to 1.0

SECONDARY outcome

Timeframe: Baseline

Difference will be reported as percent of (SUVmax.tumor - SUVmax.background)/SUVmax.background in the baseline scan with 95% Confidence Interval

Outcome measures

Outcome measures
Measure	Treatment (AMT-PET, Telotristat Etiprate) n=4 Participants 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. Carbon C 11 Alpha-methyltryptophan: Undergo AMT-PET Laboratory Biomarker Analysis: Correlative studies Positron Emission Tomography: Undergo AMT-PET Telotristat Etiprate: Given PO
Difference in SUVmax of AMT Uptake Between the Tumor Mass and Background at Baseline	451.90 Percentage Interval 271.21 to 632.6

Adverse Events

Treatment (AMT-PET, Telotristat Etiprate)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony F. Shields, MD, PhD

Barbara Ann Karmanos Cancer Institute

Phone: 313-576-8735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place