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Completed

NCT Number: NCT01677910

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.

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Key information

Conditions

Carcinoid Syndrome Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Serotonin Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lexicon Investigational Site, Kogara, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telotristat etiprate

Drug

Telotristat etiprate tablets.

Other names: LX1606

Placebo-matching telotristat etiprate

Drug

Placebo-matching telotristat etiprate tablets.

Primary outcomes

  1. Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks

    Time frame: Baseline and 12 Weeks

    Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period

    Time frame: First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.

  3. Number of Participants With TEAEs in the Open-Label Extension Period

    Time frame: First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks)

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.

Secondary outcomes

  1. Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels

    Time frame: Baseline and Week 12

    u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.

  2. Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points

    Time frame: Baseline and 12 Weeks

    Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.

  3. Change From Baseline in Abdominal Pain Averaged Across All Time-Points

    Time frame: Baseline and 12 Weeks

    Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2012
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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