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Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

NCT07087054 · Crinetics Pharmaceuticals Inc.
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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
About this study
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
Inclusion Criteria: * 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 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. Exclusion Criteria: * 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 or cervix in situ, 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. * 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
Study design
Enrollment target: 141 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-11-19
Estimated completion: 2030-01
Last updated: 2026-03-10
Interventions
Drug: PaltusotineDrug: Placebo
Primary outcomes
  • 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)
Sponsor
Crinetics Pharmaceuticals Inc. · industry
Contacts & investigators
ContactCrinetics Clinical Trials · contact · clinicaltrials@crinetics.com · 833-276-4636
All locations (43)
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
Hoag Memorial Hospital PresbyterianRecruiting
Newport Beach, California, United States
Yale University - New Haven Hospital - Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Winshop Cancer Institute - Emory UniversityRecruiting
Atlanta, Georgia, United States
University of Iowa Health CareRecruiting
Iowa City, Iowa, United States
University of Kentucky Medical CenterRecruiting
Lexington, Kentucky, United States
Louisiana State University Health SciencesRecruiting
Metairie, Louisiana, United States
Henry Ford Cancer - DetroitRecruiting
Detroit, Michigan, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Hospital of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Huntsman Cancer Institute, University of UtahRecruiting
Salt Lake City, Utah, United States
University of Virginia Comprehensive Cancer CenterRecruiting
Charlottesville, Virginia, United States
Medical College of WisconcinRecruiting
Milwaukee, Wisconsin, United States
Hospital de Gastroenterologia Dr. Carlos Bonorino UdaondoRecruiting
Buenos Aires, Argentina
Sanatorio GuemesWithdrawn
Buenos Aires, Argentina
Centro de Endocrinologia y Diabetes Dr. A. Gutman ICM - InvestigacionesRecruiting
Buenos Aires, Argentina
Instituto Médico Especializado Alexander FlemingRecruiting
Buenos Aires, Argentina
Instituto Médico de la Fundación Estudios ClínicosRecruiting
Santa Fe, Argentina
AC Camargo Cancer CenterRecruiting
São Paulo, Brazil, Brazil
Sociedade Literaria e Caritativa Santos Agostinho - Hospital Sao JoséRecruiting
Criciúma, Brazil
Nucleo de Pesquisa e Desenvolvimento de Medicamentos (MPDM)Recruiting
Fortaleza, Brazil
Associacao Hospitalar Moinhos de VentoRecruiting
Porto Alegre, Brazil
Centro de Oncologia de PrecisionRecruiting
Santiago, Chile, Chile
Hospital Universitario San IgnacioRecruiting
Bogotá, DC, Colombia
Instituto Nacional de CancerologiaRecruiting
Bogotá, DC, Colombia
CHRU Tours - Hopital TrousseauRecruiting
Chambray-lès-Tours, France
Hopital Beaujun - APHPRecruiting
Clichy, France
APHM- Hopital de la TimoneRecruiting
Marseille, France
Centre Hospitalier Universitaire NantesRecruiting
Nantes, France
Centre Antoine LacassagneRecruiting
Nice, France
CHU Bordeaux - Hopital Haut-LevequeRecruiting
Pessac, France
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
King's College HospitalRecruiting
London, UK, United Kingdom
Oxford University Hospitals NHS Foundation TrustRecruiting
Oxford, UK, United Kingdom
University Hospital of WalesRecruiting
Cardiff, United Kingdom
The Beatson WOS Cancer CentreRecruiting
Glasgow, United Kingdom
NIHR Clinical Research Facility, Royal Hallamshire HospitalRecruiting
Sheffield, United Kingdom
University Hospital Southampton NHS Foundation TrustRecruiting
Southampton, United Kingdom
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen · TrialPath