Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Crinetics Pharmaceuticals Inc.
Study ID
NCT07087054
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Carcinoid
  • Carcinoid Intestine Tumor
  • Carcinoid Syndrome
  • Carcinoid Syndrome Diarrhea
  • Carcinoid Tumor
  • Carcinoid Tumor of Cecum
  • Carcinoid Tumor of Ileum
  • Carcinoid Tumor of Liver
  • Carcinoid Tumor of Pancreas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paltusotine — DRUG
    Experimental Drug: Randomized
  • Placebo — DRUG
    Matching Placebo Drug: Randomized

Study Details

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.

Key Dates

Start date
Nov 19, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Jan 31, 2030

Study Design

Enrollment
141 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Paltusotine 80 mg daily
  • Placebo Comparator: Placebo

Primary Outcome Measure

Participants will record the number of flushing per day in a daily diary to assess the efficacy of paltusotine vs placebo in reducing flushing episodes. [ Time Frame: Measured at Week 12 ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
Yale University - New Haven Hospital - Yale Cancer CenterNew HavenConnecticut06510-
University of MiamiMiamiFlorida33136-
Moffitt Cancer CenterTampaFlorida33612-
Winshop Cancer Institute - Emory UniversityAtlantaGeorgia30322-
University of Iowa Health CareIowa CityIowa52242-
University of Kentucky Medical CenterLexingtonKentucky40536-
Louisiana State University Health SciencesMetairieLouisiana70006-
Henry Ford Cancer - DetroitDetroitMichigan48202-
Mayo ClinicRochesterMinnesota55905-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112-
University of Virginia Comprehensive Cancer CenterCharlottesvilleVirginia22903-
Medical College of WisconcinMilwaukeeWisconsin53222-

Find similar trials in Gilbert, AZ

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
Banner MD Anderson Cancer Center· Gilbert, AZHoag Memorial Hospital Presbyterian· Newport Beach, CAYale University - New Haven Hospital - Yale Cancer Center· New Haven, CTUniversity of Miami· Miami, FLMoffitt Cancer Center· Tampa, FLWinshop Cancer Institute - Emory University· Atlanta, GA

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