Phase 3 Study to Evaluate the Safety and Effectiveness of Daily Oral Paltusotine in Adults with Carcinoid Syndrome from Well-Differentiated Neuroendocrine Tumors

What this Trial Is About

Researchers are evaluating the effectiveness and safety of paltusotine compared to a placebo in adults with carcinoid syndrome caused by well-differentiated neuroendocrine tumors. This Phase 3 study aims to continue assessing the safety, efficacy, and how the body processes paltusotine. Carcinoid syndrome symptoms include flushing and frequent bowel movements, and the study focuses on these symptoms in affected adults. Participants are randomly assigned to receive either paltusotine at a dose of 80 mg daily or a placebo. The study includes several phases a screening period of up to 11 weeks to determine eligibility, a 16-week double-blinded treatment period where neither participants nor researchers know who receives the drug or placebo, followed by a 104-week open-label extension where all participants can receive paltusotine. After treatment, there is a 4-week follow-up period. During the study, participants will record daily flushing episodes and bowel movements using a diary to help measure the treatment effects. Researchers will monitor safety and treatment response throughout all phases. The total participation time can last over two years, including the screening, treatment, extension, and follow-up periods. This long-term approach helps assess both immediate and extended effects of paltusotine.

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen