Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life L⦠(NCT04073017) | Clinical Trial Compass
TerminatedNot Applicable
Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency
Stopped: Low accrual
United States11 participantsStarted 2019-11-04
Plain-language summary
This is an open-label phase II basket study evaluating the ability of enteradeĀ® to reduce bowel frequency in neuroendocrine tumor (NET) patients with carcinoid syndrome and non-carcinoid syndrome.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
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 ā„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 enteradeĀ® as instructed will be eligible.
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