Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms (TELEPATH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Lexicon Pharmaceuticals
Information provided by (Responsible Party):
Lexicon Pharmaceuticals Identifier:
First received: December 31, 2013
Last updated: February 13, 2015
Last verified: February 2015

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)

Resource links provided by NLM:

Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of treatment-emergent adverse events [ Time Frame: 50 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life measures [ Time Frame: Baseline and every 24 weeks ] [ Designated as safety issue: No ]
    EORTC QLQ-C30 (a questionnaire developed to assess the quality of life of cancer patients) and GI.NET21 (module intended for use among patients with G.I.-related neuroendocrine tumours) quality of life questionnaires

Estimated Enrollment: 160
Study Start Date: December 2013
Estimated Primary Completion Date: June 2018 (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


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

Inclusion Criteria:

  • Ongoing participation in a Phase 2 (LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 (LX1606.1-301-CS, LX1606.1-303-CS) study
  • Patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of <1% per year) during the study and for 12 weeks after the Follow-up visit.
  • Ability and willingness to provide written informed consent

Exclusion Criteria:

  • Major protocol violations or tolerability concerns in a Phase 2 (eg, LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 (eg, LX1606.1-301-CS, LX1606.1-303-CS) study
  • Positive pregnancy test
  • Presence of any clinically significant findings at entry for medical history, laboratory values, or physical examination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02026063

Contact: Shanna Jackson, Clinical Trial Manager 281-863-3484

United States, Alabama
Lexicon Investigational Site Recruiting
Mobile, Alabama, United States, 36604
United States, California
Lexicon Investigational Site Recruiting
Stanford, California, United States, 94305
United States, Iowa
Lexicon Investigational Site Recruiting
Iowa City, Iowa, United States, 52242
United States, Kentucky
Lexicon Investigational Site Recruiting
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Lexicon Investigational Site Recruiting
Boston, Massachusetts, United States, 02215
Australia, Queensland
Lexicon Investigational Site Recruiting
Herston, Queensland, Australia, 4029
Canada, Alberta
Lexicon Investgational Site Recruiting
Calgary, Alberta, Canada, T2N4N2
Canada, Nova Scotia
Lexicon Investigational Site Recruiting
Halifax, Nova Scotia, Canada, B0J1N0
Lexicon Investigational Site Recruiting
Lyon, France, 69437
Lexicon Investigational Site Recruiting
Bad Berka, Germany, 99437
Lexicon Investigational Site Recruiting
Berlin, Germany, 13353
Lexicon Investigational Site Recruiting
Hamburg, Germany, 20246
Lexicon Investigational Site Recruiting
Torino, Italy, 10043
Lexicon Investigational Site Recruiting
Madrid, Spain, 28034
Lexicon Investigational Site Recruiting
Seville, Spain, 41013
Lexicon Investigational Site Recruiting
Uppsala, Sweden, 75185
United Kingdom
Lexicon Investigational Site Recruiting
London, United Kingdom, NW32QG
Lexicon Investigational Site Recruiting
Manchester, United Kingdom, M204BX
Sponsors and Collaborators
Lexicon Pharmaceuticals
Study Director: Pablo Lapuerta, MD Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Lexicon Pharmaceuticals Identifier: NCT02026063     History of Changes
Other Study ID Numbers: LX1606.1-302-CS, LX1606.302
Study First Received: December 31, 2013
Last Updated: February 13, 2015
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Malignant Carcinoid Syndrome
Carcinoid Tumor
Neuroendocrine Tumors
Serotonin Syndrome
Chemically-Induced Disorders
Drug-Related Side Effects and Adverse Reactions
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors processed this record on March 03, 2015