Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Condition(s) studied
Investigational drug(s) / intervention(s)
Paltusotine: Experimental Drug: Randomized
Placebo: Matching Placebo Drug: Randomized
Study 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
Primary outcome measure(s)
- Participants will record the number of flushing per day in a daily diary to assess the efficacy of paltusotine vs placebo in reducing flushing episodes. — Measured at Week 12
Treatment group difference of change from baseline to Week 12 in flushing episodes/day averaged over the 14 days prior to Week 12.
Trial sites (73)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | Recruiting |
| Yale University - New Haven Hospital - Yale Cancer Center | New Haven | Connecticut | Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Winshop Cancer Institute - Emory University | Atlanta | Georgia | Recruiting |
| University of Iowa Health Care | Iowa City | Iowa | Recruiting |
| University of Kentucky Medical Center | Lexington | Kentucky | Recruiting |
| Louisiana State University Health Sciences | Metairie | Louisiana | Recruiting |
| Henry Ford Cancer - Detroit | Detroit | Michigan | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | Recruiting |
| University of Virginia Comprehensive Cancer Center | Charlottesville | Virginia | Recruiting |
| Medical College of Wisconcin | Milwaukee | Wisconsin | Recruiting |
| Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo | Buenos Aires | Argentina | Recruiting |
| Sanatorio Guemes | Buenos Aires | Argentina | Withdrawn |
| Centro de Endocrinologia y Diabetes Dr. A. Gutman ICM - Investigaciones | Buenos Aires | Argentina | Recruiting |
| Instituto Médico Especializado Alexander Fleming | Buenos Aires | Argentina | Recruiting |
| Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo | CABA | Argentina | Recruiting |
| Instituto Médico de la Fundación Estudios Clínicos | Santa Fe | Argentina | Recruiting |
| Universitair Ziekenhuis (UZ) Leuven | Leuven | Belgium | Recruiting |
| Fundacao PIO XII - Hospital de Amor Barretos | Barretos | Brazil | Recruiting |
| Sociedade Literaria e Caritativa Santos Agostinho - Hospital Sao José | Criciúma | Brazil | Recruiting |
| Nucleo de Pesquisa e Desenvolvimento de Medicamentos (MPDM) | Fortaleza | Brazil | Recruiting |
| Associacao Hospitalar Moinhos de Vento | Porto Alegre | Brazil | Recruiting |
| Instituto Nacional de Cancer (INCA) | Rio de Janeiro | Brazil | Recruiting |
| AC Camargo Cancer Center | São Paulo | Brazil | Recruiting |
| Clinical Universidad Catolica del Maule, Ltda | Maule | Chile | Recruiting |
| Centro de Oncologia de Precision | Santiago | Chile | Recruiting |
| CECIM-Centro de Estudios Cliicos e Investigaciones Medicas | Santiago | Chile | Recruiting |
| Hospital Universitario San Ignacio | Bogotá | DC | Recruiting |
| Instituto Nacional de Cancerologia | Bogotá | DC | Recruiting |
| CHRU Tours - Hopital Trousseau | Chambray-lès-Tours | France | Recruiting |
| Hopital Beaujun - APHP | Clichy | France | Recruiting |
| APHM- Hopital de la Timone | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire Nantes | Nantes | France | Recruiting |
| Centre Antoine Lacassagne | Nice | France | Recruiting |
+ 33 more sites — see the full list on the official registry below.
More Crinetics Pharmaceuticals Inc. trials in Belgium
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07087054 on ClinicalTrials.gov ↗ ← All trials in Belgium