Last updated 34 days ago
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
141 patients around the world
Available in Brazil, Argentina, United States
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.
Crinetics Pharmaceuticals Inc.
7Research sites
141Patients around the world
This study is for people with
Pancreatic cancer
Carcinoid tumor
Advanced carcinoid tumor
Non-advanced carcinoid tumor
Gastrointestinal Cancer
Liver cancer
Carcinoid Syndrome
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Centro Gutman
Recruiting
Fundación Sanatorio Güemes - CABA, Buenos Aires
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital de Gastroenterología Dr.Carlos Bonorino Udaondo
Recruiting
AC Camargo Cancer Center
Recruiting
Centro de Oncología de Precisión - Santiago de Chile
Recruiting
StudyCAREFNDR
SponsorCrinetics Pharmaceuticals Inc.
Study typeInterventional
Conditions
Pancreatic cancerAdvanced carcinoid tumorNon-advanced carcinoid tumorGastrointestinal CancerLiver cancerCarcinoid Syndrome
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07087054
