ClinicaliQ Trial Snapshot
- Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen — Recruiting • Phase III • Oncology • NCT07087054.
- What is being tested: Paltusotine, an oral daily medication, is being evaluated against placebo in a Phase 3 randomized controlled trial to assess its efficacy and safety for managing carcinoid syndrome symptoms in adults with well-differentiated neuroendocrine tumors.
- Patient eligibility overview: The study recruits adults diagnosed with carcinoid syndrome secondary to well-differentiated neuroendocrine tumors; specific inclusion/exclusion criteria would typically encompass disease stage, symptom severity, organ function, and prior treatment history.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.