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RECRUITING
NCT07087054
PHASE3

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Sponsor: Crinetics Pharmaceuticals Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

141

Start Date

2025-11-19

Completion Date

2030-01

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

DRUG

Paltusotine

Experimental Drug: Randomized

DRUG

Placebo

Matching Placebo Drug: Randomized

Locations (43)

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

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

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

Centro de Oncologia de Precision

Santiago, Chile, 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

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

University Hospital of Wales

Cardiff, United Kingdom

The Beatson WOS Cancer Centre

Glasgow, United Kingdom

NIHR Clinical Research Facility, Royal Hallamshire Hospital

Sheffield, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom