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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02026063
First Posted: January 1, 2014
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: None (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: Baseline up to Week 86 ]

Secondary Outcome Measures:
  • Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQC30 Score at Each Visit [ Time Frame: Baseline, Week 24, 48, 72 and 84 ]
  • Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit [ Time Frame: Baseline, Week 24, 48, 72 and 84 ]
  • Percentage of Participants With Adequate Relief as per Subjective Global Assessment Question [ Time Frame: Baseline, Week 12, 24, 36, 48, 60, 72 and 84 ]
  • Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on an 11-Point Numeric Scale at Each Visit [ Time Frame: Baseline, Week 12, 24, 36, 48, 60, 72 and 84 ]

Enrollment: 71
Actual Study Start Date: January 14, 2014
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026063


  Show 43 Study Locations
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Pablo Lapuerta, MD Lexicon Pharmaceuticals, Inc.
  More Information

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02026063     History of Changes
Other Study ID Numbers: LX1606.1-302-CS
LX1606.302 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Submitted: December 31, 2013
First Posted: January 1, 2014
Last Update Posted: July 14, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Syndrome
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Disease
Pathologic Processes
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