Education and Training
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Telotristat etiprate
- drug: Placebo-matching telotristat etiprate
Eligibility
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting