Phase 3
Completed N=124
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
Carcinoid Syndrome
Source: ClinicalTrials.gov NCT02026063 ↗
Enrolled (actual)
124
Serious AEs
53.2%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 22; 100 Participants
◆ Published Evidence
Emerging
13citations · ~3 / year
Long-Term Treatment with Telotristat Ethyl in Patients with Carcinoid Syndrome Symptoms: Results from the TELEPATH Study.
Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
Linked Publications
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Long-Term Treatment with Telotristat Ethyl in Patients with Carcinoid Syndrome Symptoms: Results from the TELEPATH Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
22; 100 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit |
60.664; -0.980; -4.261; -1.840; 0.309; 79.958 | — |
| SECONDARY Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit |
25.000; 1.726; 1.111; 1.425; 4.938; 25.014 | — |
| SECONDARY Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question |
61.6; 64.2; 52.9; 57.9; 61.1; 55.1 | — |
| SECONDARY Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit |
3.022; 0.558; 0.654; 0.630; 1.056; 0.576 | — |
Eligibility Criteria
Inclusion Criteria
- Ongoing participation in a Phase 2 [LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS (NCT01104415)] or Phase 3 [LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS (NCT02063659)] 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
Data sourced from ClinicalTrials.gov (NCT02026063) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.