UCSF Helen Diller Family Comprehensive Cancer Center
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Protocol No.124521Principal InvestigatorBergsland, Emily
PhaseIII
Age GroupAdultScopeNational
Secondary Protocol No.LX1606.1-301-CS
TitleA Phase 3, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients with Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog (SSA) Therapy
ObjectiveThe primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the change from baseline in the number of daily bowel movements (BMs) averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients refractory to current SSA therapy
Key EligibilityAge: 18+ * Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor * Documented history of carcinoid syndrome and currently experiencing ≥4 bowel movements per day during the Run-in period * Currently receiving stable-dose somatostatin analog (SSA) therapy
Applicable Disease SitesColon
Other Digestive Organ
Rectum
Small Intestine
Stomach
StatusOpen
Participating InstitutionsMt. Zion
Eligibility Document124521_CTGovEligibility_NCT01677910.doc