RecruitingPhase III🇵🇱 PolandEN originalOther cancersMetastatic / advanced

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek 18 lat lub więcej
  • Potwierdzona diagnoza zespołu karcinoidu wymagająca leczenia
  • Średnio więcej niż 1 atak zaczerwienienia na dzień przez 14 dni
  • Potwierdzony nowotwór neuroendokrynny rozprzestrzeniający się na inne narządy lub tkanki
  • Brak znacznego pogorszenia się choroby w ciągu ostatnich 6 miesięcy
  • Gotowość do prowadzenia dziennika objawów przez 2 tygodnie ze zgodą co najmniej 70%

✗ Disqualifies

  • Biegunka spowodowana inną chorobą niż zespół karcinoidu
  • Ciężka biegunka ze znacznym odwodnieniem organizmu
  • Konieczność zastosowania innych leków drugiej linii do kontroli objawów
  • Leczenie chemią lub radioterapia mniej niż 4 tygodnie przed badaniem
  • Duża operacja chirurgiczna w ciągu 8 tygodni przed badaniem
  • Historia innego nowotworu w ciągu ostatnich 3 lat (z wyjątkami na skórę)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 4, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (67)

Banner MD Anderson Cancer Center

Gilbert, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, United States

Yale University - New Haven Hospital - Yale Cancer Center

New Haven, United States

University of Miami

Miami, United States

Moffitt Cancer Center

Tampa, United States

Winshop Cancer Institute - Emory University

Atlanta, United States

University of Iowa Health Care

Iowa City, United States

University of Kentucky Medical Center

Lexington, United States

Louisiana State University Health Sciences

Metairie, United States

Henry Ford Cancer - Detroit

Detroit, United States

Mayo Clinic

Rochester, United States

Icahn School of Medicine at Mount Sinai

New York, United States

University Hospitals Cleveland Medical Center

Cleveland, United States

Hospital of the University of Pennsylvania

Philadelphia, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, United States

University of Virginia Comprehensive Cancer Center

Charlottesville, United States

Medical College of Wisconcin

Milwaukee, 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

Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

CABA, Argentina

Instituto Médico de la Fundación Estudios Clínicos

Santa Fe, Argentina

AC Camargo Cancer Center

São Paulo, 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

Centro de Oncologia de Precision

Santiago, Chile

CECIM-Centro de Estudios Cliicos e Investigaciones Medicas

Santiago, Chile

Hospital Universitario San Ignacio

Bogotá, Colombia

Instituto Nacional de Cancerologia

Bogotá, 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

Asklepios Kilnic St. Georg

Hamburg, Germany

Universitätsklinikum Marburg (UKGM)

Marburg, Germany

Instituto Europeo di Oncologia

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino

Turin, Italy

Health Pharma Professional Research S.A de C.V.

Mexico City, Mexico

Centro de Oncolégica VIVA

Mexico City, Mexico

Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach

Katowice, Poland

Centrum Diagnostyczno-Lecznicze ,,GAMMED"

Warsaw, Poland

Wokskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Centrum Wsparcia Badań Klinicznych

Warsaw, Poland

Institute of Oncology Bucharest

Bucharest, Romania

Institute of Oncology "Prof. Dr. Ion Chiricuta" Cluj Napoca

Cluj-Napoca, Romania

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Fundacion Jimenez Diaz University Hospital

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitario y Politecnico La Fe

Valencia, Spain

King's College Hospital

London, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, 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

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/5/2026.

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