Status:
WITHDRAWN
Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
Lead Sponsor:
Andrew Hendifar, MD
Collaborating Sponsors:
Lexicon Pharmaceuticals
Conditions:
Pancreatic Cancer
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Brief Summary
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 tu...
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 sy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04034745
Start Date
October 1 2020
End Date
November 1 2023
Last Update
December 30 2020
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