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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
141
Experimental Drug: Randomized
Matching Placebo Drug: Randomized
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGHoag Memorial Hospital Presbyterian
Newport Beach, California, United States
RECRUITINGYale University - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
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
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.
Treatment group difference of change from baseline to Week 12 in BMs/day averaged over the 14 days prior to Week 12.
Time frame: Measured at Week 12
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Winshop Cancer Institute - Emory University
Atlanta, Georgia, United States
RECRUITINGUniversity of Iowa Health Care
Iowa City, Iowa, United States
RECRUITINGUniversity of Kentucky Medical Center
Lexington, Kentucky, United States
RECRUITINGLouisiana State University Health Sciences
Metairie, Louisiana, United States
RECRUITINGHenry Ford Cancer - Detroit
Detroit, Michigan, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITING...and 33 more locations