Open Label Study To Analyze The Effect Of Telotristat Ethyl On Weight Regulation/Gain

Study Overview

Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain

This single arm study will evaluate whether Xermelo (telotristat ethyl) associated weight gain is affects lean body mass, dietary intake, and physical and cognitive functioning among neuroendocrine tumor (NET) patients with a history of carcinoid syndrome.

The purpose of this study is to examine the mechanisms of weight gain associated with the drug telotristat ethyl (Xermelo) among patients with a neuroendocrine tumor (NET) with history of carcinoid syndrome. We want to know if taking Xermelo affects patients' lean body mass, quality of life, dietary intake, and physical and cognitive functioning during treatment. A better understanding of the mechanisms of weight gain from Xermelo may allow us to determine whether this drug may be beneficial for treating carcinoid syndrome, cachexia, or weight loss seen in other diseases.

Pancreatic Cancer
Neuroendocrine Tumors
Cachexia; Cancer

DRUG: telotristat ethyl

IIT2018-26 -Hendifar-NETCx

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-06-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-12-29
First Submitted that Met QC Criteria 2019-07-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-12-30
First Posted (ACTUAL) 2019-07-26	Results First Posted N/A	Last Verified 2020-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Standard of Care telotristat ethyl (Xermelo) Treatment Treatment of telotristat ethyl (Xermelo) with DXA scans and bionutritional assessments (24-hour food recall and taste/smell alteration) conducted 3x during telotristat ethyl treatment.	DRUG: telotristat ethyl 250 mg tablets of Xermelo (telotristat ethyl) is administered orally 3x daily in combination with somatostatin analogs (SSAs) for approximately 84 days as per standard of care

Participant Group/Arm

Intervention/Treatment

: Standard of Care telotristat ethyl (Xermelo) Treatment

Treatment of telotristat ethyl (Xermelo) with DXA scans and bionutritional assessments (24-hour food recall and taste/smell alteration) conducted 3x during telotristat ethyl treatment.

DRUG: telotristat ethyl

250 mg tablets of Xermelo (telotristat ethyl) is administered orally 3x daily in combination with somatostatin analogs (SSAs) for approximately 84 days as per standard of care

Primary Outcome Measures	Measure Description	Time Frame
Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.		From baseline to 13 weeks after treatment

Secondary Outcome Measures	Measure Description	Time Frame
Mean change in patient reported outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from baseline up to 3 years post treatment.	The summary score (SS) is a mean of 13 QLQ-C30 subscale scores, ranging from 0 to 100, with a higher SS rating reflecting a better health status.	From baseline to 3 years post treatment
Mean change in patient reported outcomes using the Montreal Cognitive Assessment (MOCA) test from baseline up to 3 years post treatment.	MOCA scores range between 0 and 30, with higher scores indicating higher cognitive function.	From baseline to 3 years post treatment
Mean change in patient reported outcomes using a stool survey measured from baseline and after 13 weeks of treatment.	The stool survey is a non-validated descriptive measure of gastrointestinal symptoms by taking the mean score on a scale of 0 - 10, where 0 indicates no symptoms and higher scores denote a worsening of symptoms.	From baseline to 13 weeks post-treatment.
Mean change in calories consumed using a 24-hour food diary from baseline and after 13 weeks of treatment.		From baseline to 13 weeks post-treatment
Mean change in daily activity levels (steps) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.		From baseline to 13 weeks post-treatment
Mean change in daily activity levels [stairs (floors) climbed] as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.		From baseline to 13 weeks post-treatment
Mean change in daily activity levels (sleep duration) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.		From baseline to 13 weeks post-treatment
Mean change in daily activity levels (heart rate) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.		From baseline to 13 weeks post-treatment
Mean change in daily activity levels (active minutes) as measured using a wrist-worn fitness tracker (e.g., Fitbit) from baseline and for the duration of the 13 weeks of treatment.		From baseline to 13 weeks post-treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age ≥ 18 years.
Histopathologically confirmed diagnosis of a metastatic NET.
Documented history of carcinoid syndrome.
Currently receiving treatment with long-acting SSAs with a plan to initiate therapy with telotristat-ethyl as per standard of care.
ECOG performance status 0-1 and/or Karnofsky >60%.
Greater than or equal to 3 month life expectancy.
Ability to understand and the willingness to sign a written informed consent.

Patients experiencing more than 12 watery BMs per day associated with volume contraction, dehydration, or hypotension, or showing evidence of enteric infection.
History of short bowel syndrome.
Clinically important baseline elevation in liver function tests.
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Malignant ascites requiring paracenteses.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Bowel obstruction, partial, or total.
Pregnancy
Patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment, other than diarrhea

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Lexicon Pharmaceuticals

Investigators

PRINCIPAL_INVESTIGATOR: Andrew Hendifar, MD, MPH, Cedars-Sinai Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record