RecruitingPhase 3NCT07087054

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors


Sponsor

Crinetics Pharmaceuticals Inc.

Enrollment

141 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a daily oral medication called paltusotine for people with carcinoid syndrome — a condition where certain slow-growing tumors (usually in the digestive tract) release hormones that cause flushing of the face and frequent loose bowel movements. Most current treatments require regular injections, so this study is testing an easy-to-take daily pill. **You may be eligible if...** - You are 18 or older - You have been diagnosed with carcinoid syndrome requiring medical treatment - You experience frequent flushing episodes (more than 1 per day on average) if not currently on somatostatin injections, or an increase in flushing after stopping injections - You are willing and able to keep a daily symptom diary **You may NOT be eligible if...** - Your symptoms are fully controlled on current injections and cannot be safely stopped - You have poorly controlled carcinoid-related heart valve disease - You have serious liver or heart conditions unrelated to carcinoid syndrome - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaltusotine

Experimental Drug: Randomized

DRUGPlacebo

Matching Placebo Drug: Randomized


Locations(51)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Yale University - New Haven Hospital - Yale Cancer Center

New Haven, Connecticut, United States

University of Miami

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winshop Cancer Institute - Emory University

Atlanta, Georgia, United States

University of Iowa Health Care

Iowa City, Iowa, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Louisiana State University Health Sciences

Metairie, Louisiana, United States

Henry Ford Cancer - Detroit

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States

Medical College of Wisconcin

Milwaukee, Wisconsin, United States

Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

Buenos Aires, Argentina

Sanatorio Guemes

Buenos Aires, Argentina

Centro de Endocrinologia y Diabetes Dr. A. Gutman ICM - Investigaciones

Buenos Aires, Argentina

Instituto Médico Especializado Alexander Fleming

Buenos Aires, Argentina

Instituto Médico de la Fundación Estudios Clínicos

Santa Fe, Argentina

AC Camargo Cancer Center

São Paulo, Brazil, Brazil

Fundacao PIO XII - Hospital de Amor Barretos

Barretos, Brazil

Sociedade Literaria e Caritativa Santos Agostinho - Hospital Sao José

Criciúma, Brazil

Nucleo de Pesquisa e Desenvolvimento de Medicamentos (MPDM)

Fortaleza, Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Brazil

Instituto Nacional de Cancer (INCA)

Rio de Janeiro, Brazil

Clinical Universidad Catolica del Maule, Ltda

Maule, Chile, Chile

Centro de Oncologia de Precision

Santiago, Chile, Chile

CECIM-Centro de Estudios Cliicos e Investigaciones Medicas

Santiago, Chile

Hospital Universitario San Ignacio

Bogotá, DC, Colombia

Instituto Nacional de Cancerologia

Bogotá, DC, Colombia

CHRU Tours - Hopital Trousseau

Chambray-lès-Tours, France

Hopital Beaujun - APHP

Clichy, France

APHM- Hopital de la Timone

Marseille, France

Centre Hospitalier Universitaire Nantes

Nantes, France

Centre Antoine Lacassagne

Nice, France

CHU Bordeaux - Hopital Haut-Leveque

Pessac, France

Centro de Oncolégica VIVA

Mexico City, Mexico

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

King's College Hospital

London, UK, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, UK, United Kingdom

Queen Elizabeth Hospital Brimingham

Birmingham, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

The Beatson WOS Cancer Centre

Glasgow, United Kingdom

Royal Free Hospital

London, United Kingdom

NIHR Clinical Research Facility, Royal Hallamshire Hospital

Sheffield, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07087054


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