Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Start Date
11/19/2025
Completion Date
1/1/2030
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.
Detailed Description
This is a global, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of paltusotine in adults with carcinoid syndrome. The study includes a screening period of up to 11 weeks, a double-blinded randomized control period of 16 weeks, an open label extension period of 104 weeks, and a follow-up period of 4 weeks.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Paltusotine
Placebo
Conditions
Locations
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United States
Yale University - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut 06510
United States
University of Miami
Miami, Florida 33136
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Winshop Cancer Institute - Emory University
Atlanta, Georgia 30322
United States
University of Iowa Health Care
Iowa City, Iowa 52242
United States
University of Kentucky Medical Center
Lexington, Kentucky 40536
United States
Louisiana State University Health Sciences
Metairie, Louisiana 70006
United States
Henry Ford Cancer - Detroit
Detroit, Michigan 48202
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112
United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia 22903
United States
Medical College of Wisconcin
Milwaukee, Wisconsin 53222
United States
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
Buenos Aires, 1264
Argentina
Sanatorio Guemes
Buenos Aires, C1180AAX
Argentina
Centro de Endocrinologia y Diabetes Dr. A. Gutman ICM - Investigaciones
Buenos Aires, C1425BGH
Argentina
Instituto Médico Especializado Alexander Fleming
Buenos Aires, C1426ANZ
Argentina
Instituto Médico de la Fundación Estudios Clínicos
Santa Fe, 2000
Argentina
AC Camargo Cancer Center
São Paulo, Brazil 01509-010
Brazil
Fundacao PIO XII - Hospital de Amor Barretos
Barretos, 14784-400
Brazil
Sociedade Literaria e Caritativa Santos Agostinho - Hospital Sao José
Criciúma, 88811-000
Brazil
Nucleo de Pesquisa e Desenvolvimento de Medicamentos (MPDM)
Fortaleza, 60430-275
Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90560-032
Brazil
Instituto Nacional de Cancer (INCA)
Rio de Janeiro, 20230-130
Brazil
Clinical Universidad Catolica del Maule, Ltda
Maule, Chile 3460000
Chile
Centro de Oncologia de Precision
Santiago, Chile 7560908
Chile
CECIM-Centro de Estudios Cliicos e Investigaciones Medicas
Santiago, 8320000
Chile
Hospital Universitario San Ignacio
Bogotá, DC 110231
Colombia
Instituto Nacional de Cancerologia
Bogotá, DC 110411
Colombia
CHRU Tours - Hopital Trousseau
Chambray-lès-Tours, 37170
France
Hopital Beaujun - APHP
Clichy, 92110
France
APHM- Hopital de la Timone
Marseille, 13005
France
Centre Hospitalier Universitaire Nantes
Nantes, 44093
France
Centre Antoine Lacassagne
Nice, 06100
France
CHU Bordeaux - Hopital Haut-Leveque
Pessac, 33600
France
Centro de Oncolégica VIVA
Mexico City, 06760
Mexico
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
King's College Hospital
London, UK SE59RS
United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, UK OX37LE
United Kingdom
Queen Elizabeth Hospital Brimingham
Birmingham, B15 2TH
United Kingdom
University Hospital of Wales
Cardiff, CF144XW
United Kingdom
The Beatson WOS Cancer Centre
Glasgow, G120YN
United Kingdom
Royal Free Hospital
London, NW3 2QG
United Kingdom
NIHR Clinical Research Facility, Royal Hallamshire Hospital
Sheffield, S102JF
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, SO166YD
United Kingdom