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

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoid Syndrome

In brief

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.

Key facts

Study ID

NCT01677910

Run by

Lexicon Pharmaceuticals

People needed

135

Starts

2013-01-08

Expected to finish

2016-03-21

Last updated by the study team

2018-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify 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

Where it is running

• Lexicon Investigational Site — Palo Alto, California, United States
• Lexicon Investigational Site — San Francisco, California, United States
• Lexicon Investigational Site — Orlando, Florida, United States
• Lexicon Investigational Site — Iowa City, Iowa, United States
• Lexicon Investigational Site — Lexington, Kentucky, United States
• Lexicon Investigational Site — Kenner, Louisiana, United States
• Lexicon Investigational Site — Boston, Massachusetts, United States
• Lexicon Investigational Site — Boston, Massachusetts, United States
• Lexicon Investigational Site — Omaha, Nebraska, United States
• Lexicon Investigational Site — Buffalo, New York, United States
• Lexicon Investigational Site — New York, New York, United States
• Lexicon Investigational Site — Durham, North Carolina, United States
• Lexicon Investigational Site — Philadelphia, Pennsylvania, United States
• Lexicon Investigational Site — Fort Worth, Texas, United States
• Lexicon Investigational Site — Houston, Texas, United States
• Lexicon Investigational Site — McAllen, Texas, United States
• Lexicon Investigational Site — Kogara, New South Wales, Australia
• Lexicon Investigational Site — Saint Leanoards, New South Wales, Australia
• Lexicon Investigational Site — Herston, Queensland, Australia
• Lexicon Investigational Site — Fitzroy, Victoria, Australia
• Lexicon Investigational Site — Freemantle, Western Australia, Australia
• Lexicon Investigational Site — Woodville South, Australia
• Lexicon Investigational Site — Edegem, Belgium
• Lexicon Investigational Site — Ghent, Belgium
• Lexicon Investigational Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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