Status:
TERMINATED
Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
Entrinsic Bioscience Inc.
Conditions:
Neuroendocrine Tumor
Carcinoid Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an open-label phase II basket study evaluating the ability of enterade® to reduce bowel frequency in neuroendocrine tumor (NET) patients with carcinoid syndrome and non-carcinoid syndrome.
Detailed Description
Primary Objective: \- To assess the ability of enterade to reduce bowel movement frequency in NET patients with and without carcinoid syndrome. Secondary Objectives: * To assess subject-reported he...
Eligibility Criteria
Inclusion
- Carcinoid syndrome:
- Participants must have histopathologically confirmed neuroendocrine tumor with 4 or more bowel movements per day on standard anti-diarrheal regimen (which includes somatostatin analogs and/or Telotristat Ethyl). Additionally, a plasma 5-HIAA, or a urine 24-hour 5-HIAA or plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening.
- Non-Carcinoid Syndrome:
- Participants who have histopathologically confirmed neuroendocrine tumor and have 4 or more bowel movements per day on standard anti-diarrheal regimen (which may or may not include somatostatin analogs), but do not have elevated results for one of the following: plasma 5-HIAA, or 24-hour urine 5-HIAA or other plasma secretory hormone levels (VIP, gastrin) above the upper limit of normal per reference lab. Patients may be grouped into this cohort based on a previous plasma 5-HIAA level though the final cohort determination will be made based upon the 5-HIAA level drawn during screening
- ECOG performance status ≤ 2 (Karnofsky ≥60%)
- Ability to tolerate thin liquids by mouth at the time of enrollment.
- Ability to understand and the willingness to sign a written informed consent document.
- Subject who are willing to take enterade® as instructed will be eligible.
Exclusion
- Known allergy to Stevia.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
- Clostridium difficile infection or history of Clostridium difficile infection.
- Participants with a history of inflammatory bowel disease, irritable bowel syndrome, bariatric surgery and/or Celiac disease.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who have had enterade® within the past 3 months.
- Pregnant or breastfeeding women. The safety of enterade® has not been validated in this patient population.
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04073017
Start Date
November 4 2019
End Date
May 18 2021
Last Update
May 21 2021
Active Locations (1)
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1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232