OncoMatch/Clinical Trials/NCT07087054
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Is NCT07087054 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Paltusotine for carcinoid syndrome.
Treatment: Paltusotine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Disease stage
Required: Stage III, IV
Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor(s) [NETs]
Prior therapy
Cannot have received: targeted therapy (everolimus, sunitinib)
Treatment with specific NET therapy <4 weeks before Screening (such as everolimus or sunitinib)
Cannot have received: hepatic embolization
hepatic embolization <12 weeks before Screening
Cannot have received: radiation therapy
radiotherapy <12 weeks before Screening
Cannot have received: peptide receptor radionuclide therapy
peptide receptor radionuclide therapy (PRRT) <12 weeks before Screening
Cannot have received: tumor debulking
tumor debulking <12 weeks before Screening
Cannot have received: surgery
Major surgery within 8 weeks before Screening
Lab requirements
Kidney function
estimated glomerular filtration rate 2×upper limit of normal [ULN]
Liver function
total bilirubin (TB) >1.5×ULN (except Gilbert's syndrome); see text
Cardiac function
clinically significant cardiovascular disease
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...)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
- Yale University - New Haven Hospital - Yale Cancer Center · New Haven, Connecticut
- Moffitt Cancer Center · Tampa, Florida
- Winshop Cancer Institute - Emory University · Atlanta, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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