TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

• Status: Completed
• Trial end date: 2016-03-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals
• Treatments: Somatostatin

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 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

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, 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