Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

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 ID
NCT07087054
Phase
PHASE3
Sponsor
Crinetics Pharmaceuticals Inc.
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Paltusotine
  • Placebo
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Newport Beach, California, United States|33.61891,-117.92895
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Miami, Florida, United States|25.77427,-80.19366
  • Atlanta, Georgia, United States|33.749,-84.38798

Key Eligibility Criteria

  • Male or female ≥18 years of age, at the time of Screening.
  • Willing and able to comply with the study procedures as specified in the protocol, including at least 70% compliance with the study diary for the 2…
  • Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or without frequent BMs as follows:
  • For participants who are naïve/not currently treated with somatostatin receptors ligands (SRL), they must exhibit an average of \>1 flushing episod…

For full eligibility, visit ClinicalTrials.gov.

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