Carcinoid SyndromePhase 3CAREFNDRNCT07087054
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
A Phase 3 study testing Paltusotine in people with Carcinoid Syndrome and Carcinoid, run by Crinetics Pharmaceuticals Inc. at 72 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor
- What is being tested?
- Paltusotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 72 sitesin 14 countries
- Study dates
- 19 Nov 2025to Jan 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age, at the time of Screening.
- Willing and able to comply with the study procedures as specified in the protocol, including at least 70% compliance with the study diary for the 2-week period.
- Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or without frequent BMs as follows:
- For participants who are naïve/not currently treated with somatostatin receptors ligands (SRL), they must exhibit an average of >1 flushing episode/day over a period of 14 days
- For participants who will wash out from SRL treatment, they must be symptomatically controlled and exhibit an increase in daily average flushing episodes and an average of >1 flushing episode/day over a period of 14 days during the Washout Period.
- Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor(s) [NETs].
- No significant disease progression as assessed by the Investigator within the last 6 months before randomization.
Who cannot join
- Diarrhea attributed to any condition(s) other than carcinoid syndrome.
- Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension.
- Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms in the opinion of the Investigator.
- Treatment with specific NET therapy <4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or tumor debulking <12 weeks before Screening.
- Major surgery within 8 weeks before Screening.
- History of another primary malignancy <3 years prior to the date of randomization, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast has been completely locally excised and carcinoma in situ of the cervix has also been resected, previously treated malignancy, if all treatment for that malignancy was completed at least 3 years prior to first dose of study treatment, and no current evidence of disease, concurrent malignancy determined to be clinically stable and not requiring treatment.
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- Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.
- Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%
- Unable to administer short-acting (SA) octreotide (octreotide acetate injection), or prior nonresponse documented with somatostatin agonists.
- Clinically significant concomitant disease or indicator of disease that is not a result of the primary disease under study, including but not limited to cardiovascular disease, estimated glomerular filtration rate 2×upper limit of normal [ULN], and/or total bilirubin (TB) >1.5×ULN. (Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with TB
- Alcohol or drug abuse is not permitted at any time during the study
- Diagnosed with symptomatic cholelithiasis
Trial locations and contacts
72 sites in 14 countries.
72 sites in 14 countries
United States17 sites
Winshop Cancer Institute - Emory University
Atlanta, Georgia, 30322
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Henry Ford Cancer - Detroit
Detroit, Michigan, 48202
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
University of Iowa Health Care
Iowa City, Iowa, 52242
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Louisiana State University Health Sciences
Metairie, Louisiana, 70006
University of Miami
Miami, Florida, 33136
Medical College of Wisconcin
Milwaukee, Wisconsin, 53222
Yale University - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, 06510
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Moffitt Cancer Center
Tampa, Florida, 33612
France8 sites
CHRU Tours - Hopital Trousseau
Chambray-lès-Tours, 37170
Hopital Beaujun - APHP
Clichy, 92110
APHM- Hopital de la Timone
Marseille, 13005
Centre Hospitalier Universitaire Nantes
Nantes, 44093
Centre Antoine Lacassagne
Nice, 06100
Groupe Hospitalier Diaconsses Croix Saint Simon
Paris, 75020
CHU Bordeaux - Hopital Haut-Leveque
Pessac, 33600
CHU Toulouse
Toulouse, 31059
United Kingdom8 sites
Queen Elizabeth Hospital Brimingham
Birmingham, B15 2TH
University Hospital of Wales
Cardiff, CF144XW
The Beatson WOS Cancer Centre
Glasgow, G120YN
King's College Hospital
London, UK, SE59RS
Royal Free Hospital
London, NW3 2QG
Oxford University Hospitals NHS Foundation Trust
Oxford, UK, OX37LE
NIHR Clinical Research Facility, Royal Hallamshire Hospital
Sheffield, S102JF
University Hospital Southampton NHS Foundation Trust
Southampton, SO166YD
Spain7 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Ramon y Cajal
Madrid, 28034
Fundacion Jimenez Diaz University Hospital
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Universitario y Politecnico La Fe
Valencia, 46026
Brazil6 sites
Fundacao PIO XII - Hospital de Amor Barretos
Barretos, 14784-400
Sociedade Literaria e Caritativa Santos Agostinho - Hospital Sao José
Criciúma, 88811-000
Nucleo de Pesquisa e Desenvolvimento de Medicamentos (MPDM)
Fortaleza, 60430-275
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90560-032
Instituto Nacional de Cancer (INCA)
Rio de Janeiro, 20230-130
AC Camargo Cancer Center
São Paulo, Brazil, 01509-010
Argentina5 sites
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
Buenos Aires, 1264
Centro de Endocrinologia y Diabetes Dr. A. Gutman ICM - Investigaciones
Buenos Aires, C1425BGH
Instituto Médico Especializado Alexander Fleming
Buenos Aires, C1426ANZ
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
CABA, 1264
Instituto Médico de la Fundación Estudios Clínicos
Santa Fe, 2000
Italy5 sites
IRCCS Azienda Ospedaliera - Universitaria di Bologna
Bologna, 40138
Instituto Europeo di Oncologia
Milan, 20141
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00136
Azienda ospedaliero - Universitaria Sant'Andrea
Rome, 00189
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Turin, 10126
Poland4 sites
Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-154
Centrum Diagnostyczno-Lecznicze ,,GAMMED"
Warsaw, 02-351
Wokskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Centrum Wsparcia Badań Klinicznych
Warsaw, 04-141
Dolnośląskie Centrum Onkologii, Hematologii i Pulmonologii; FutureMeds Wroclaw
Wroclaw, 53-673
Chile3 sites
Clinical Universidad Catolica del Maule, Ltda
Maule, Chile, 3460000
Centro de Oncologia de Precision
Santiago, Chile, 7560908
CECIM-Centro de Estudios Cliicos e Investigaciones Medicas
Santiago, 8320000
Colombia2 sites
Hospital Universitario San Ignacio
Bogotá, DC, 110231
Instituto Nacional de Cancerologia
Bogotá, DC, 110411
Germany2 sites
Asklepios Kilnic St. Georg
Hamburg, 20099
Universitätsklinikum Marburg (UKGM)
Marburg, 35043
Mexico2 sites
Health Pharma Professional Research S.A de C.V.
Mexico City, 03100
Centro de Oncolégica VIVA
Mexico City, 06760
Romania2 sites
Institute of Oncology Bucharest
Bucharest, 022328
Institute of Oncology "Prof. Dr. Ion Chiricuta" Cluj Napoca
Cluj-Napoca, 400015
About this study
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
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.
Read the 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.
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum, Carcinoid Tumor of Cecum, Carcinoid Tumor of Liver
- Being tested
- Paltusotine, Placebo
- Keywords
- Neuroendocrine tumor, Paltusotine, CRN00808, Carcinoid syndrome, Lanreotide, Octreotide, Somatostatin agonist
- Medical subject headings
- Serotonin Syndrome, Carcinoid Tumor, Carcinoid Tumors, Intestinal, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaltusotineDrug
Experimental Drug: Randomized
PlaceboDrug
Matching Placebo Drug: Randomized
| Study group | Role | What they receive |
|---|---|---|
| Paltusotine 80 mg daily | Experimental | Not described Receives: Drug: Paltusotine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Treatment group difference of change from baseline to Week 12 in flushing episodes/day averaged over the 14 days prior to Week 12.
Measured: Measured at Week 12
Secondary outcomes (1)
Participants will record the number of bowel movements (BMs) per day in a daily diary to assess the efficacy of paltusotine vs placebo in reducing BMs/day.
Treatment group difference of change from baseline to Week 12 in BMs/day averaged over the 14 days prior to Week 12.
Measured: Measured at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start19 Nov 2025
- Primary completionAug 2027 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoid SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087054
- Sponsor's protocol ID
- CRN00808-12
- Other IDs
- 2024-519875-24-00
- Acronym
- CAREFNDR
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No