Clinical trial NCT02026063: Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
Official title: A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoid Syndrome
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-01-01
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)
Secondary outcomes:
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit
timeFrame: Baseline, Weeks 24, 48, 72 and 84
measure: Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit
timeFrame: Baseline, Weeks 24, 48, 72 and 84
measure: Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
measure: Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Lexicon Investigational Site
state: Alabama
city: Stanford
country: United States
facility: Lexicon Investigational Site
state: California
city: Iowa City
country: United States
facility: Lexicon Investigational Site
state: Iowa
city: Lexington
country: United States
facility: Lexicon Investigational Site
state: Kentucky
city: Boston
country: United States
facility: Lexicon Investigational Site
state: Massachusetts
city: New York
country: United States
facility: Lexicon Investigational Site
state: New York
city: Philadelphia
country: United States
facility: Lexicon Investigational Site
state: Pennsylvania
city: St. Leonards
country: Australia
facility: Lexicon Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: Lexicon Investigational Site
state: Queensland
city: East Melbourne
country: Australia
facility: Lexicon Investigational Site
state: Victoria
city: Edegem
country: Belgium
facility: Lexicon Investigational Site
city: Ghent
country: Belgium
facility: Lexicon Investigational Site
city: Yvoir
country: Belgium
facility: Lexicon Investigational Site
city: Calgary
country: Canada
facility: Lexicon Investgational Site
state: Alberta
city: Halifax
country: Canada
facility: Lexicon Investigational Site
state: Nova Scotia
city: Lille
country: France
facility: Lexicon Investigational Site
city: Lyon
country: France
facility: Lexicon Investigational Site
city: Villejuif
country: France
facility: Lexicon Investigational Site
city: Bad Berka
country: Germany
facility: Lexicon Investigational Site
city: Berlin
country: Germany
facility: Lexicon Investigational Site
city: Essen
country: Germany
facility: Lexicon Investigational Site
city: Hamburg
country: Germany
facility: Lexicon Investigational Site
city: Marburg
country: Germany
facility: Lexicon Investigational Site
city: Jerusalem
country: Israel
facility: Lexicon Investigational Site
city: Milano
country: Italy
facility: Lexicon Investigational Site
city: Milano
country: Italy
facility: Lexicon Investigational Site
city: Pisa
country: Italy
facility: Lexicon Investigational Site
city: Torino
country: Italy
facility: Lexicon Investigational Site
city: Amsterdam
country: Netherlands
facility: Lexicon Investigational Site
city: Noord Holland
country: Netherlands
facility: Lexicon Investigational Site
city: Noord-Brahant
country: Netherlands
facility: Lexicon Investigational Site
city: Barcelona
country: Spain
facility: Lexicon Investigational Site
city: Madrid
country: Spain
facility: Lexicon Investigational Site
city: Seville
country: Spain
facility: Lexicon Investigational Site
city: Lund
country: Sweden
facility: Lexicon Investigational Site
city: Uppsala
country: Sweden
facility: Lexicon Investigational Site
city: Coventry
country: United Kingdom
facility: Lexicon Investigational Site
city: Glasgow
country: United Kingdom
facility: Lexicon Investigational Site
city: London
country: United Kingdom
facility: Lexicon Investigational Site
city: London
country: United Kingdom
facility: Lexicon Investigational Site
city: London
country: United Kingdom
facility: Lexicon Investigational Site
city: Manchester
country: United Kingdom
facility: Lexicon Investigational Site
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Lexicon Investigational Site
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Pablo Lapuerta, MD
role: STUDY_DIRECTOR
References:
citation: Horsch D, Anthony L, Gross DJ, Valle JW, Welin S, Benavent M, Caplin M, Pavel M, Bergsland E, Oberg K, Kassler-Taub KB, Binder P, Banks P, Lapuerta P, Kulke MH. Long-Term Treatment with Telotristat Ethyl in Patients with Carcinoid Syndrome Symptoms: Results from the TELEPATH Study. Neuroendocrinology. 2022;112(3):298-310. doi: 10.1159/000516958. Epub 2021 May 3.