Telotristat With Lutathera in Neuroendocrine Tumors

NCT ID: NCT04543955

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-13
• Study Completion Date: 2022-06-03

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).

Detailed Description

Neuroendocrine tumors (NETs) are a very heterogeneous group of tumors that develop predominantly in the gastrointestinal and pulmonary systems. Clinical detection and diagnosis are more reliable at late stages when metastatic spread has occurred. Patients with advanced disease may suffer from complications of uncontrolled hormone secretion and usually succumb due to tumor progression.

This trial tests the hypothesis that inhibition of serotonin production with Telotristat will lead to cytostatic effects on neuroendocrine tumors and will complement the anti-tumor activity of Lutetium 177 Dotatate. The proposed combination may result in improved treatment efficacy as reflected by improved 20-month progression-free survival (PFS) as compared to historical control.

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Low-Dose Telotristat

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

Group Type: EXPERIMENTAL

Telotristat (Low-Dose)

Intervention Type: 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.

Arm 2: High-Dose Telotristat

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

Group Type: EXPERIMENTAL

Telotristat (High-Dose)

Intervention Type: 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.

Interventions

Telotristat (Low-Dose)

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.

Intervention Type: DRUG

Telotristat (High-Dose)

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.

Intervention Type: DRUG

Other Intervention Names

Xermelo; Xermelo

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TerSera Therapeutics LLC

INDUSTRY

Sponsor Role: collaborator

Lowell Anthony, MD

OTHER

Sponsor Role: lead

Responsible Party

Lowell Anthony, MD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lowell Anthony, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Markey Cancer Center

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MCC-20-GI-114-PMC

Identifier Type: -

Identifier Source: org_study_id