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

This study is currently recruiting participants.
Verified April 2014 by Lexicon Pharmaceuticals
Information provided by (Responsible Party):
Lexicon Pharmaceuticals Identifier:
First received: August 30, 2012
Last updated: April 15, 2014
Last verified: April 2014

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.

Condition Intervention Phase
Carcinoid Syndrome
Drug: Telotristat etiprate tablets (250 mg)
Drug: Placebo tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in number of daily bowel movements [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in urinary 5-hydroxyindoleacetic acid (5-HIAA) levels [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the number of cutaneous flushing episodes [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in abdominal pain [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 105
Study Start Date: October 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 250 mg telotristat etiprate
One telotristat etiprate (250 mg) tablet administered three times daily
Drug: Telotristat etiprate tablets (250 mg)
Other Name: LX1606
Experimental: 500 mg telotristat etiprate
Two telotristat etiprate (250 mg) tablets administered three times daily
Drug: Telotristat etiprate tablets (250 mg)
Other Name: LX1606
Placebo Comparator: Placebo
Placebo administered three times daily
Drug: Placebo tablets
One placebo tablet administered three times daily
Experimental: 500 mg telotristat etiprate open label extension
Two 250 mg telotristat etiprate tablets three times daily in a 36-week open-label Extension period
Drug: Telotristat etiprate tablets (250 mg)
Other Name: LX1606


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01677910

Contact: Shanna Jackson, Project manager 281-863-3000

  Show 60 Study Locations
Sponsors and Collaborators
Lexicon Pharmaceuticals
Study Director: Doug Fleming, MD Lexicon Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Lexicon Pharmaceuticals Identifier: NCT01677910     History of Changes
Other Study ID Numbers: LX1606.1-301-CS, LX1606.301
Study First Received: August 30, 2012
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Malignant Carcinoid Syndrome
Serotonin Syndrome
Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug Toxicity
Substance-Related Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014