Actively Recruiting
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors
Led by Crinetics Pharmaceuticals Inc. · Updated on 2026-04-30
141
Participants Needed
51
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of paltusotine, an oral medication, in adults with carcinoid syndrome caused by well-differentiated neuroendocrine tumors. This Phase 3 study aims to continue understanding how paltusotine works and its safety profile compared to a placebo. The study is sponsored by Crinetics Pharmaceuticals Inc. and includes adults aged 18 years and older with carcinoid syndrome who experience flushing and bowel movement symptoms. Participants will be randomly assigned to receive either paltusotine 80 mg daily or a matching placebo during a 16-week double-blinded treatment period. The study also includes a screening period lasting up to 11 weeks before randomization. Following the blinded phase, there is a 104-week open-label extension where all participants may receive paltusotine, and finally a 4-week follow-up period after treatment ends. During the study, participants will keep daily diaries to record flushing episodes and bowel movements to assess treatment effects, especially at week 12. They will undergo regular safety and efficacy assessments throughout all study periods. Compliance with the study diary and procedures is monitored. The total participation time spans the screening, treatment, extension, and follow-up periods, allowing researchers to evaluate both short- and long-term outcomes of paltusotine treatment.
CONDITIONS
Brief Title
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at screening
- Willing and able to follow study procedures, including at least 70% compliance with study diary during a 2-week period
- Documented carcinoid syndrome needing medical therapy with symptoms of flushing, with or without frequent bowel movements
- Participants not treated with somatostatin receptor ligands (SRL) must have an average of more than 1 flushing episode per day over 14 days
- Participants washing out from SRL treatment must show increased flushing episodes averaging more than 1 per day over 14 days during washout
- Confirmed well-differentiated neuroendocrine tumor(s) locally advanced or metastatic
- No significant disease progression within 6 months before randomization
You will not qualify if you...
- Diarrhea caused by conditions other than carcinoid syndrome
- Uncontrolled or severe diarrhea with volume loss, dehydration, or low blood pressure
- Need for second-line treatments like telotristat for symptom control
- Treatment with certain neuroendocrine tumor therapies (e.g., everolimus, sunitinib) or procedures (hepatic embolization, radiotherapy, PRRT, tumor debulking) within specified weeks before screening
- Major surgery within 8 weeks before screening
- History of other primary cancers within 3 years before randomization, except certain treated skin or in situ cancers
- Insulin-treated diabetes less than 6 weeks before study entry
- Poorly controlled diabetes with HbA1c of 8.5% or higher
- Inability to use short-acting octreotide or documented nonresponse to somatostatin agonists
- Significant other diseases not related to carcinoid syndrome, including certain heart, kidney, or liver function issues
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 11 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 16 weeks
Participants receive either the experimental drug paltusotine or placebo daily to evaluate efficacy and safety.
Visits as scheduled during the 16-week treatment period
Duration - 104 weeks
Participants continue with open-label paltusotine treatment to assess long-term efficacy and safety.
Visits as scheduled during the open-label extension period
Duration - 4 weeks
Participants are monitored for safety and outcomes after completing treatment.
1 follow-up visit
Trial Site Locations
Total: 51 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
3
Yale University - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
5
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
6
Winshop Cancer Institute - Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
9
Louisiana State University Health Sciences
Metairie, Louisiana, United States, 70006
Actively Recruiting
10
Henry Ford Cancer - Detroit
Detroit, Michigan, United States, 48202
Actively Recruiting
11
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
12
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
13
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
14
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
16
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
17
Medical College of Wisconcin
Milwaukee, Wisconsin, United States, 53222
Actively Recruiting
18
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
Buenos Aires, Argentina, 1264
Actively Recruiting
19
Sanatorio Guemes
Buenos Aires, Argentina, C1180AAX
Withdrawn
20
Centro de Endocrinologia y Diabetes Dr. A. Gutman ICM - Investigaciones
Buenos Aires, Argentina, C1425BGH
Actively Recruiting
21
Instituto Médico Especializado Alexander Fleming
Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
22
Instituto Médico de la Fundación Estudios Clínicos
Santa Fe, Argentina, 2000
Actively Recruiting
23
AC Camargo Cancer Center
São Paulo, Brazil, Brazil, 01509-010
Actively Recruiting
24
Fundacao PIO XII - Hospital de Amor Barretos
Barretos, Brazil, 14784-400
Actively Recruiting
25
Sociedade Literaria e Caritativa Santos Agostinho - Hospital Sao José
Criciúma, Brazil, 88811-000
Actively Recruiting
26
Nucleo de Pesquisa e Desenvolvimento de Medicamentos (MPDM)
Fortaleza, Brazil, 60430-275
Actively Recruiting
27
Associacao Hospitalar Moinhos de Vento
Porto Alegre, Brazil, 90560-032
Actively Recruiting
28
Instituto Nacional de Cancer (INCA)
Rio de Janeiro, Brazil, 20230-130
Actively Recruiting
29
Clinical Universidad Catolica del Maule, Ltda
Maule, Chile, Chile, 3460000
Actively Recruiting
30
Centro de Oncologia de Precision
Santiago, Chile, Chile, 7560908
Actively Recruiting
31
CECIM-Centro de Estudios Cliicos e Investigaciones Medicas
Santiago, Chile, 8320000
Actively Recruiting
32
Hospital Universitario San Ignacio
Bogotá, DC, Colombia, 110231
Actively Recruiting
33
Instituto Nacional de Cancerologia
Bogotá, DC, Colombia, 110411
Actively Recruiting
34
CHRU Tours - Hopital Trousseau
Chambray-lès-Tours, France, 37170
Actively Recruiting
35
Hopital Beaujun - APHP
Clichy, France, 92110
Actively Recruiting
36
APHM- Hopital de la Timone
Marseille, France, 13005
Actively Recruiting
37
Centre Hospitalier Universitaire Nantes
Nantes, France, 44093
Actively Recruiting
38
Centre Antoine Lacassagne
Nice, France, 06100
Actively Recruiting
39
CHU Bordeaux - Hopital Haut-Leveque
Pessac, France, 33600
Actively Recruiting
40
Centro de Oncolégica VIVA
Mexico City, Mexico, 06760
Actively Recruiting
41
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
42
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
43
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
44
King's College Hospital
London, UK, United Kingdom, SE59RS
Actively Recruiting
45
Oxford University Hospitals NHS Foundation Trust
Oxford, UK, United Kingdom, OX37LE
Actively Recruiting
46
Queen Elizabeth Hospital Brimingham
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
47
University Hospital of Wales
Cardiff, United Kingdom, CF144XW
Actively Recruiting
48
The Beatson WOS Cancer Centre
Glasgow, United Kingdom, G120YN
Actively Recruiting
49
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
50
NIHR Clinical Research Facility, Royal Hallamshire Hospital
Sheffield, United Kingdom, S102JF
Actively Recruiting
51
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO166YD
Actively Recruiting
Research Team
C
Crinetics Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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