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
Summary
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.
Detailed description
This is a global, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of paltusotine in adults with carcinoid syndrome. The study includes a screening period of up to 11 weeks, a double-blinded randomized control period of 16 weeks, an open label extension period of 104 weeks, and a follow-up period of 4 weeks.
Arms & interventions
- DrugPaltusotine
Experimental Drug: Randomized
- DrugPlacebo
Matching Placebo Drug: Randomized
Outcome measures
Primary
Participants will record the number of flushing per day in a daily diary to assess the efficacy of paltusotine vs placebo in reducing flushing episodes.
Treatment group difference of change from baseline to Week 12 in flushing episodes/day averaged over the 14 days prior to Week 12.
Time frame: Measured at Week 12
Secondary
Participants will record the number of bowel movements (BMs) per day in a daily diary to assess the efficacy of paltusotine vs placebo in reducing BMs/day.
Time frame: Measured at Week 12
Eligibility criteria
Study locations (17)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Yale University - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, 06510
University of Miami
Miami, Florida, 33136
Moffitt Cancer Center
Tampa, Florida, 33612
Winshop Cancer Institute - Emory University
Atlanta, Georgia, 30322
University of Iowa Health Care
Iowa City, Iowa, 52242
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Louisiana State University Health Sciences
Metairie, Louisiana, 70006
Henry Ford Cancer - Detroit
Detroit, Michigan, 48202
Mayo Clinic
Rochester, Minnesota, 55905
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
Medical College of Wisconcin
Milwaukee, Wisconsin, 53222