TELESTAR (Telotristat Etiprate for Somatostatin Analogue Refractory Carcinoid Syndrome)

Status: Recruiting
Diagnosis: Gastrointestinal Malignancies
NCT ID: NCT01677910 (View complete trial on
DFCI Protocol ID: 13-057


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 change from baseline in the number of daily bowel movements (BMs) averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients refractory to current SSA therapy.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Matthew Kulke, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

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 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 Exclusion Criteria: - 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, 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, or QTcF >450 ms - Previous exposure to telotristat etiprate
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