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 Somatostatin Analog (SSA) therapy.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Placebo tablets
- drug : Telotristat etiprate tablets (250 mg)
Phase: Phase 3
Ages Eligible For Study:
- 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 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