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Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Study acronym: CAREFNDR
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoing
    • Study sites: 73 to 72
  2. Trial sites expanded: 67 → 73 locations
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 1 entry
  3. Trial sites expanded: 51 → 67 locationsv10
  4. Eligibility criteria expanded, about 33 wordsv9
  5. Trial sites expanded: 43 → 51 locationsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 37 to 43v7
  2. Study sites: 26 to 37v6
  3. Start date changed from estimate of Nov 2025 to Nov 19, 2025
    • Site details revised at 1 of 26 sites
    v5
  4. Study sites: 10 to 26
    • Start date: Oct 2025 to Nov 2025
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Start date: Aug 2025 to Oct 2025
    • Study sites: 2 to 10
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in participants with carcinoid syndrome.
Trial Details
NCT Number NCT07087054
Lead Sponsor Crinetics Pharmaceuticals Inc.
Conditions
(from sponsor)		 Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum, Carcinoid Tumor of Cecum, Carcinoid Tumor of Liver, Carcinoid Tumor of Pancreas, Carcinoid Syndrome Diarrhea +1 more
Related terms Carcinoid Tumor, Carcinoid Tumors, Intestinal, Neuroendocrine Tumors, Serotonin Syndrome
Enrollment 141 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov