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

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ClinicalTrials.gov Identifier: NCT02026063
Recruitment Status : Active, not recruiting
First Posted : January 1, 2014
Last Update Posted : July 14, 2017
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Carcinoid Syndrome Drug: Telotristat etiprate tablets (250 mg) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
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)
Actual Study Start Date : January 14, 2014
Estimated Primary Completion Date : June 2018

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Baseline up to Week 86 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Percentage of Participants With Adequate Relief as per Subjective Global Assessment Question [ Time Frame: Baseline, Week 12, 24, 36, 48, 60, 72 and 84 ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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
Study Director: Pablo Lapuerta, MD Lexicon Pharmaceuticals, Inc.

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 Posted: January 1, 2014    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

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