Clinical Trial Finder

Telotristat With Lutathera in Neuroendocrine Tumors

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 AEs of previously administered therapeutic agents to Grade 2 or less toxicity according to CTCAE version 5.0.
  • - 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.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04543955
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Aman Chauhan
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Aman Chauhan, MD
Principal Investigator Affiliation University of Kentucky
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Neuroendocrine Tumors
Additional Details

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.

Arms & Interventions

Arms

Experimental: Arm 1: Low-Dose Telotristat

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

Experimental: Arm 2: High-Dose Telotristat

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

Interventions

Drug: - 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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Markey Cancer Center, Lexington, Kentucky

Status

Recruiting

Address

Markey Cancer Center

Lexington, Kentucky, 40536

Site Contact

Aman Chauhan, MD

amanchauhan@uky.edu

8592572862

Powered By

Stay Informed & Connected