Trial Search Results

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 Somatostatin Analog (SSA) therapy.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Lexicon Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Telotristat etiprate tablets (250 mg)
  • Drug: Placebo tablets

Phase:

Phase 3

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 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

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