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Clinical Trials in the UK / NCT07087054
Recruiting Phase 3

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

NCT07087054 · tracked via the Priya Life Science UK tracker
Sponsor
Crinetics Pharmaceuticals Inc.
Phase
Phase 3
Started
2025-11-19
Last updated
2026-09-15

Condition(s) studied

Carcinoid SyndromeCarcinoidCarcinoid TumorCarcinoid Tumor of IleumCarcinoid Tumor of CecumCarcinoid Tumor of LiverCarcinoid Tumor of PancreasCarcinoid Syndrome DiarrheaCarcinoid Intestine Tumor

Investigational drug(s) / intervention(s)

PaltusotinePlacebo

Paltusotine: Experimental Drug: Randomized

Placebo: Matching Placebo Drug: Randomized

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion 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-week period. * 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 episode/day over a period of 14 days * For participants who will wash out from SRL treatment, they must be symptomatically controlled and exhibit an increase in daily average flushing episodes and an average of \>1 flushing episode/day over a period of 14 days during the Washout Period. * Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor(s) \[NETs\]. * No significant disease progression as assessed by the Investigator within the last 6 months before randomization. Exclusion Criteria: * Diarrhea attributed to any condition(s) other than carcinoid syndrome. * Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension. * Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms in the opinion of the Investigator. * Treatment with specific NET therapy \<4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or tumor debulking \<12 weeks before Screening. * Major surgery within 8 weeks before Screening. * History of another primary malignancy \<3 years prior to the date of randomization, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast has been completely locally excised and carcinoma in situ of the cervix has also been resected, previously treated malignancy, if all treatment for that malignancy was completed at least 3 years prior to first dose of study treatment, and no current evidence of disease, concurrent malignancy determined to be clinically stable and not requiring treatment. * Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry. * Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5% * Unable to administer short-acting (SA) octreotide (octreotide acetate injection), or prior nonresponse documented with somatostatin agonists. * Clinically significant concomitant disease or indicator of disease that is not a result of the primary disease under study, including but not limited to cardiovascular disease, estimated glomerular filtration rate 2×upper limit of normal \[ULN\], and/or total bilirubin (TB) \>1.5×ULN. (Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with TB * Alcohol or drug abuse is not permitted at any time during the study * Diagnosed with symptomatic cholelithiasis

Primary outcome measure(s)

Trial sites (73)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
Yale University - New Haven Hospital - Yale Cancer Center New Haven Connecticut Recruiting
University of Miami Miami Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Winshop Cancer Institute - Emory University Atlanta Georgia Recruiting
University of Iowa Health Care Iowa City Iowa Recruiting
University of Kentucky Medical Center Lexington Kentucky Recruiting
Louisiana State University Health Sciences Metairie Louisiana Recruiting
Henry Ford Cancer - Detroit Detroit Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Hospital of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
Huntsman Cancer Institute, University of Utah Salt Lake City Utah Recruiting
University of Virginia Comprehensive Cancer Center Charlottesville Virginia Recruiting
Medical College of Wisconcin Milwaukee Wisconsin Recruiting
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo Buenos Aires Argentina Recruiting
Sanatorio Guemes Buenos Aires Argentina Withdrawn
Centro de Endocrinologia y Diabetes Dr. A. Gutman ICM - Investigaciones Buenos Aires Argentina Recruiting
Instituto Médico Especializado Alexander Fleming Buenos Aires Argentina Recruiting
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo CABA Argentina Recruiting
Instituto Médico de la Fundación Estudios Clínicos Santa Fe Argentina Recruiting
Universitair Ziekenhuis (UZ) Leuven Leuven Belgium Recruiting
Fundacao PIO XII - Hospital de Amor Barretos Barretos Brazil Recruiting
Sociedade Literaria e Caritativa Santos Agostinho - Hospital Sao José Criciúma Brazil Recruiting
Nucleo de Pesquisa e Desenvolvimento de Medicamentos (MPDM) Fortaleza Brazil Recruiting
Associacao Hospitalar Moinhos de Vento Porto Alegre Brazil Recruiting
Instituto Nacional de Cancer (INCA) Rio de Janeiro Brazil Recruiting
AC Camargo Cancer Center São Paulo Brazil Recruiting
Clinical Universidad Catolica del Maule, Ltda Maule Chile Recruiting
Centro de Oncologia de Precision Santiago Chile Recruiting
CECIM-Centro de Estudios Cliicos e Investigaciones Medicas Santiago Chile Recruiting
Hospital Universitario San Ignacio Bogotá DC Recruiting
Instituto Nacional de Cancerologia Bogotá DC Recruiting
CHRU Tours - Hopital Trousseau Chambray-lès-Tours France Recruiting
Hopital Beaujun - APHP Clichy France Recruiting
APHM- Hopital de la Timone Marseille France Recruiting
Centre Hospitalier Universitaire Nantes Nantes France Recruiting
Centre Antoine Lacassagne Nice France Recruiting

+ 33 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07087054 on ClinicalTrials.gov ↗ ← All trials in the UK