Phase 3 N=124 Treatment

Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

Carcinoid Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02026063 ↗

Enrolled (actual)

124

Serious AEs

53.2%

Results posted

Sep 2019

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 22; 100 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Telotristat etiprate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lexicon Pharmaceuticals
Primary completion: Sep 2018

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	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02026063). 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.