OncoMatch/Clinical Trials/NCT07087054
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Is NCT07087054 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Neuroendocrine Tumor
Pancreatic Cancer
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 →Frequently asked questions
Is NCT07087054 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior targeted therapy, hepatic embolization, radiation therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages