A 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
A 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
The 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 number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.
Inclusion Criteria:
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
Minimum dose of long-acting release (LAR) or depot SSA therapy
Ability and willingness to provide written informed consent
Exclusion Criteria:
Kogara, New South Wales 2217, Australia
Saint Leanoards, New South Wales 2065, Australia
Freemantle, Western Australia 6160, Australia
Noord-Brahant, 5631BM, Netherlands
Noord-Holland, 1066CX, Netherlands
Zuid-Holland, 3015E, Netherlands
Basingstoke-Hampshire, RG249NA, United Kingdom
Headington-Oxford, OX37LJ, United Kingdom