Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
NCT ID: NCT07087054
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
141 participants
INTERVENTIONAL
2025-11-19
2030-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Paltusotine 80 mg daily
Paltusotine
Experimental Drug: Randomized
Placebo
Placebo
Matching Placebo Drug: Randomized
Interventions
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Paltusotine
Experimental Drug: Randomized
Placebo
Matching Placebo Drug: Randomized
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Crinetics Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Yale University - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States
Winshop Cancer Institute - Emory University
Atlanta, Georgia, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Louisiana State University Health Sciences
Metairie, Louisiana, United States
Henry Ford Cancer - Detroit
Detroit, Michigan, United States
Mayo Clinic
Rochester, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
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
Instituto Médico de la Fundación Estudios Clínicos
Santa Fe, , Argentina
AC Camargo Cancer Center
São Paulo, Brazil, Brazil
Sociedade Literaria e Caritativa Santos Agostinho - Hospital Sao José
Criciúma, , Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, , Brazil
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
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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CRN00808-12
Identifier Type: -
Identifier Source: org_study_id
2024-519875-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
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