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Completed

NCT Number: NCT02063659

Telotristat Etiprate for Carcinoid Syndrome Therapy

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

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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

  • Patients ≥ 18 years of age
  • All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit.
  • Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
  • Documented history of carcinoid syndrome
  • Patient is able and willing to provide written informed consent prior to participation

Exclusion criteria

  • Presence of diarrhea attributed to any condition other than carcinoid syndrome.
  • Presence of 12 or more watery bowel movements per day
  • Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening
  • Karnofsky Performance Status ≤ 60%
  • Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator
  • A history of short bowel syndrome
  • History of constipation within 2 years of Screening
  • Life expectancy < 12 months from Screening

Treatment and study plan

Telotristat etiprate

Drug

Telotristat etiprate tablets

Other names: LX1606

Placebo

Drug

Placebo-matching telotristat etiprate tablets

Primary outcomes

  1. 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 17.1 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.

  2. Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels

    Time frame: Baseline and 12 Weeks

    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.

  3. Number of Participants With Treatment-Emergent Adverse Events (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 52.6 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.

Secondary 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. Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points

    Time frame: Baseline and 12 Weeks

    Participants assessed stool form/consistency of a BM using the Bristol Stool Form Scale where: 1=hard lumps to 7=watery liquid. The daily scores were averaged over the 12-week period. A negative change indicates improvement.

  3. 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.

  4. 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.

  5. Change in the Frequency of Rescue Short-acting, Somatostatin Analog (SSA) Used to Treat Carcinoid Syndrome Symptoms Averaged Across All Time-Points

    Time frame: Baseline and 12 weeks

    The frequency (the number of times) the participant used rescue with SSA to control symptoms was recorded in a daily diary. The daily number of rescue treatments with SSA was averaged over the 12- week period. A negative change from Baseline (less use of SSA) indicates improvement.

  6. Change From Baseline in the Number of Daily BMs Averaged Over the 12-Week Double-Blind Period, Among Participants Who Were Not Receiving SSA Therapy at Baseline

    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.

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome

Acronym: TELECAST

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 14, 2014
Registry last updated
Feb 26, 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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