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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Lexicon Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02026063
First received: December 31, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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: December 2014 (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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT02026063

Contacts
Contact: Shanna Jackson, Clinical Trial Manager 281-863-3484 sjackson@lexpharma.com

Locations
United States, Alabama
Lexicon Investigational Site Recruiting
Mobile, Alabama, United States, 36604
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
Canada, Nova Scotia
Lexicon Investigational Site Recruiting
Halifax, Nova Scotia, Canada, B0J1N0
Germany
Lexicon Investigational Site Recruiting
Bad Berka, Germany, 99437
Lexicon Investigational Site Recruiting
Berlin, Germany, 13353
Spain
Lexicon Investigational Site Recruiting
Madrid, Spain, 28034
United Kingdom
Lexicon Investigational Site Recruiting
Manchester, United Kingdom, M204BX
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Doug Fleming, MD Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02026063     History of Changes
Other Study ID Numbers: LX1606.1-302-CS, LX1606.302
Study First Received: December 31, 2013
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 19, 2014