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

Trial ID or NCT#

NCT01677910

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase 3, Randomized, Placebo-controlled, Parallel Group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog (SSA) Therapy

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
  2. * 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:
  1. * 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
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Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine

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Contact

CCTO
650-498-7061

View on ClinicalTrials.gov