- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04034745
Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
December 29, 2020 updated by: Andrew Hendifar, MD
IIT2018-26 -Hendifar-NETCx: A Descriptive, Multicenter, Single-arm, 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.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients will be recruited from Cedars-Sinai Medical Center
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.
Time Frame: From baseline to 13 weeks after treatment
|
From baseline to 13 weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: From baseline 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.
Time Frame: From baseline 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.
Time Frame: From baseline to 13 weeks post-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.
Time Frame: From baseline to 13 weeks post-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.
Time Frame: From baseline to 13 weeks post-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.
Time Frame: From baseline to 13 weeks post-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.
Time Frame: From baseline to 13 weeks post-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.
Time Frame: From baseline to 13 weeks post-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.
Time Frame: From baseline to 13 weeks post-treatment
|
From baseline to 13 weeks post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
November 1, 2022
Study Completion (Anticipated)
November 1, 2023
Study Registration Dates
First Submitted
June 29, 2019
First Submitted That Met QC Criteria
July 25, 2019
First Posted (Actual)
July 26, 2019
Study Record Updates
Last Update Posted (Actual)
December 30, 2020
Last Update Submitted That Met QC Criteria
December 29, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT2018-26 -Hendifar-NETCx
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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