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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
Phase
Phase 3
Sponsor
Crinetics Pharmaceuticals Inc.
Enrollment
141
Timeline
Nov 2025 → Jan 2030
About This Study
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.
Eligibility Criteria
Inclusion Criteria
- 1Male or female ≥18 years of age, at the time of Screening.
- 2Willing 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.
- 3Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or without frequent BMs as follows:
- 4For 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
- 5For 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.
- 6Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor(s) \[NETs\].
- 7No significant disease progression as assessed by the Investigator within the last 6 months before randomization.
Exclusion Criteria
- 1Diarrhea attributed to any condition(s) other than carcinoid syndrome.
- 2Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension.
- 3Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms in the opinion of the Investigator.
- 4Treatment 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.
- 5Major surgery within 8 weeks before Screening.
- 6History 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.
- 7Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.
- 8Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%
- 9Unable to administer short-acting (SA) octreotide (octreotide acetate injection), or prior nonresponse documented with somatostatin agonists.
- 10Clinically 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
Locations
26 sites participating in this study
Winshop Cancer Institute - Emory University
Atlanta, Georgia 30322
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
Yale University - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut 06510
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →