Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor

StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Study completion pushed from Aug 3, 2026 to Aug 3, 2028
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 16 of 21 entries
    • Study description revised
  2. Re-verified, no change to tracked fieldsv15
  3. Results first posted: Feb 5, 2026
    • Secondary endpoints revised (21)
    v14
  4. Primary endpoint revised
    • Primary completion date changed from estimate of Oct 26, 2025 to Aug 31, 2025
    • Study completion date: Oct 26, 2025 to Aug 3, 2026
    • Secondary endpoints: 8 to 21
    v13
  5. Primary and study completion dates: Aug 26, 2025 to Oct 26, 2025v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study Identification, Study Statusv11
  2. Primary and study completion dates: Aug 31, 2024 to Aug 26, 2025v10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 60 to confirmed 79
    • Site details revised
    v9
  4. Re-verified, no change to tracked fieldsv8
  5. Primary and study completion dates: Jul 31, 2027 to Aug 31, 2024v7
  6. Primary and study completion dates: Aug 31, 2023 to Jul 31, 2027v6
  7. Collaborators shortened, about 3 wordsv5
  8. Site contact updatedv4
  9. Eligibility criteria expanded, about 3 words
    • Collaborators expanded, about 3 words
    v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 8, 2021 to May 18, 2021
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial compares the effect of telotristat ethyl and the current standard of care somatostatin analog therapy or somatostatin analog therapy alone in treating patients with neuroendocrine tumor that has spread to other places in the body (metastatic). Telotristat ethyl and somatostatin analog therapy may help to control carcinoid syndrome and carcinoid heart disease.
Trial Details
NCT Number NCT04810091
Lead Sponsor M.D. Anderson Cancer Center
Conditions
(from sponsor)		 Locally Advanced Neuroendocrine Neoplasm, Metastatic Neuroendocrine Neoplasm
Related terms Neuroendocrine Tumors
Enrollment 79 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov