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Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Sponsor: Crinetics Pharmaceuticals Inc.
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
Conditions
Interventions
Paltusotine
Experimental Drug: Randomized
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