TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
Trial ID or NCT#
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.
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
- - 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 - Octreotide LAR at 30 mg every 4 weeks - Lanreotide Depot at 120 mg every 4 weeks - Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose - Ability and willingness to provide written informed consent
- - Presence of diarrhea attributed to any condition(s) other than carcinoid syndrome - Karnofsky Performance status ≤60% - Treatment with any tumor directed therapy, including interferon, chemotherapy, mechanistic target of rapamycin (mTOR) inhibitors <4 weeks prior to Screening, or hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking <12 weeks prior to Screening - History of short bowel syndrome (SBS) - Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study - Previous exposure to telotristat etiprate
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