NCT04543955

Brief Summary

This trial will test the hypothesis that Telotristat treatment increases the antitumor efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors (NETs).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

September 13, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 27, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

September 2, 2020

Results QC Date

June 2, 2023

Last Update Submit

June 2, 2023

Conditions

Neuroendocrine Tumors

Keywords

NET

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    Progression-free survival at 20 months.

    20 months

Secondary Outcomes (5)

  • Overall Response Rate (ORR)

    6 and 12 months

  • Median Progression-Free Survival (PFS)

    36 month

  • Urinary 5-HIAA

    Baseline and 12 months

  • Quality of Life (QLQ-C30)

    20 month

  • Quality of Life (QLQ-GI.NET21)

    20 month

Study Arms (2)

Arm 1: Low-Dose Telotristat

EXPERIMENTAL

Participants in this group will receive 750mg Telotristat per day.

Drug: Telotristat (Low-Dose)

Arm 2: High-Dose Telotristat

EXPERIMENTAL

Participants in this group will receive 1500mg Telotristat per day.

Drug: Telotristat (High-Dose)

Interventions

Telotristat (Low-Dose)DRUG

Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 750mg per day (250mg TID) for 20 months.

Also known as: Xermelo
Arm 1: Low-Dose Telotristat
Telotristat (High-Dose)DRUG

Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 1500mg per day (500mg TID) for 20 months.

Also known as: Xermelo
Arm 2: High-Dose Telotristat

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic, or unresectable, histologically confirmed well-differentiated grade 1 and 2 neuroendocrine tumor with a positive gallium 68 Dotatate scan within 6 months prior to study enrollment
  • Baseline CT scan or MRI with measurable progressive disease based on RECIST Criteria
  • Failure of at least one prior systemic cancer treatment for this diagnosis
  • Recovered from Adverse Events of previously administered therapeutic agents to Grade 2 or less toxicity according to CTCAE version 5.0
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • normal organ and marrow function

You may not qualify if:

  • Prior exposure to Lutetium Lu 177 Dotatate
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Telotristat or Lutetium Lu 177 Dotatate.
  • Presence of unstable angina or myocardial infarction
  • New York Heart Association (NYHA) Class III or IV heart failure
  • uncontrolled angina
  • history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities
  • Pregnant or lactating women
  • Women of childbearing potential or male patients of reproductive potential
  • Any other significant medical or psychiatric condition, currently uncontrolled by treatment, which may interfere with completion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

telotristattelotristat ethyl

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Results Point of Contact

Title
Dr. Lowell Anthony
Organization
University of Kentucky
lowell.anthony@uky.edu
859-323-8043

Study Officials

  • Lowell Anthony, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 10, 2020

Study Start

September 13, 2021

Primary Completion

June 3, 2022

Study Completion

June 3, 2022

Last Updated

June 27, 2023

Results First Posted

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)