Telotristat Etiprate for Carcinoid Syndrome Therapy

Last updated: January 26, 2018
Sponsor: Lexicon Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Neuroendocrine Carcinoma

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT02063659
LX1606.1-303-CS
2013-001543-31
LX1606.303
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 18 years of age

  • All patients of reproductive potential must agree to use an adequate method ofcontraception 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

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, ofClostridium difficile at Screening

  • Karnofsky Performance Status ≤ 60%

  • Presence of any clinically significant laboratory, medical history, or physicalexamination 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

Study Design

Total Participants: 76
Study Start date:
March 11, 2014
Estimated Completion Date:
March 29, 2016

Connect with a study center

  • Lexicon Investigational Site

    Kogara, New South Wales 2217
    Australia

    Site Not Available

  • Lexicon Investigational Site

    St. Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Lexicon Investigational Site

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Lexicon Investigational Site

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Lexicon Investigational Site

    Edegem, B-2650
    Belgium

    Site Not Available

  • Lexicon Investigational Site

    Gent, 9000
    Belgium

    Site Not Available

  • Lexicon Investigational Site

    Yvoir, 5530
    Belgium

    Site Not Available

  • Lexicon Investigational Site

    Calgary, Alberta T2N4N2
    Canada

    Site Not Available

  • Lexicon Investigational Site

    Halifax, Nova Scotia B0J1N0
    Canada

    Site Not Available

  • Lexicon Investigational Site

    Clichy, 92118
    France

    Site Not Available

  • Lexicon Investigational Site

    Lille, 59037
    France

    Site Not Available

  • Lexicon Investigational Site

    Lyon, 69347
    France

    Site Not Available

  • Lexicon Investigational Site

    Marseille, 13385
    France

    Site Not Available

  • Lexicon Investigational Site

    Strasbourg, 67098
    France

    Site Not Available

  • Lexicon Investigational Site

    Villejuif, 94805
    France

    Site Not Available

  • Lexicon Investigational Site

    Bad Berka, 99437
    Germany

    Site Not Available

  • Lexicon Investigational Site

    Berlin, 13353
    Germany

    Site Not Available

  • Lexicon Investigational Site

    Hamburg, 20246
    Germany

    Site Not Available

  • Lexicon Investigational Site

    Heidelberg, 69120
    Germany

    Site Not Available

  • Lexicon Investigational Site

    Lubeck, 23538
    Germany

    Site Not Available

  • Lexicon Investigational Site

    Mainz, 55131
    Germany

    Site Not Available

  • Lexicon Investigational Site

    Marburg, 35043
    Germany

    Site Not Available

  • Lexicon Investigational Site

    Munchen, 81377
    Germany

    Site Not Available

  • Lexicon Investigational Site

    Munich, 81377
    Germany

    Site Not Available

  • Lexicon Investigational Site

    Neuss, 41464
    Germany

    Site Not Available

  • Lexicon Investigational Site

    Jerusalem, 91120
    Israel

    Site Not Available

  • Lexicon Investigational Site

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Site Not Available

  • Lexicon Investigational Site

    Noord Brahant, 5631BM
    Netherlands

    Site Not Available

  • Lexicon Investigative Site

    Rotterdam, 3015 CE
    Netherlands

    Site Not Available

  • Lexicon Investigational Site

    Barcelona, 08907
    Spain

    Site Not Available

  • Lexicon Investigational Site

    Madrid, 28040
    Spain

    Site Not Available

  • Lexicon Investigational Site

    Sevilla, 41013
    Spain

    Site Not Available

  • Lexicon Investigational Site

    Uppsala, 75185
    Sweden

    Site Not Available

  • Lexicon Investigational Site

    Basingstoke Hampshire, RG249NA
    United Kingdom

    Site Not Available

  • Lexicon Investigational Site

    Coventry, CV22DX
    United Kingdom

    Site Not Available

  • Lexicon Investigational Site

    London, W12 OHS
    United Kingdom

    Site Not Available

  • Lexicon Investigational Site

    Manchester, M204BX
    United Kingdom

    Site Not Available

  • Lexicon Investigational Site

    Newcastle upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Lexicon Investigational Site

    Stanford, California 94305
    United States

    Site Not Available

  • Lexicon Investigational Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • Lexicon Investigational Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Lexicon Investigational Site

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Lexicon Investigational Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Lexicon Investigational Site

    Buffalo, New York 14263
    United States

    Site Not Available

  • Lexicon Investigational Site

    New York, New York 10029
    United States

    Site Not Available

  • Lexicon Investigational Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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