At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Ascending, Multidose Study To Determine Safety and Tolerability of Orally Administered LX1606 in Subjects With Symptomatic Carcinoid Syndrome Refractory to Stable-Dose Octreotide Long-Acting Release Depot Therapy
In Brief
A Phase 2 clinical trial evaluating Telotristat etiprate, Octreotide LAR Depot, and 1 other intervention for Carcinoid Syndrome. Completed, enrolled 23 participants across 9 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.
Study Details
Timeline
Interventions
Telotristat etiprate capsules; orally 3 times daily.
A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
Placebo-matching telotristat etiprate capsules; orally 3 times daily.