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
You may not be if
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
Clareo Health | TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
