Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

Carcinoid Syndrome Clinical Trial

— TELEPATH  

Official title:

A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026063
• Other study ID #: LX1606.1-302-CS
• Secondary ID: LX1606.3022013-0
• Status: Completed
• Phase: Phase 3
• Start date: January 14, 2014
• Est. completion date: September 12, 2018

Study information

• Verified date: August 2019
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 12, 2018
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoid Syndrome
• Carcinoid Tumor
• Malignant Carcinoid Syndrome
• Serotonin Syndrome
• Syndrome

Intervention

Drug:
• Telotristat etiprate
Telotristat etiprate tablet (250 mg)

Locations

Country	Name	City	State
Australia	Lexicon Investigational Site	East Melbourne	Victoria
Australia	Lexicon Investigational Site	Herston	Queensland
Australia	Lexicon Investigational Site	St. Leonards	New South Wales
Belgium	Lexicon Investigational Site	Edegem
Belgium	Lexicon Investigational Site	Ghent
Belgium	Lexicon Investigational Site	Yvoir
Canada	Lexicon Investgational Site	Calgary	Alberta
Canada	Lexicon Investigational Site	Halifax	Nova Scotia
France	Lexicon Investigational Site	Lille
France	Lexicon Investigational Site	Lyon
France	Lexicon Investigational Site	Villejuif
Germany	Lexicon Investigational Site	Bad Berka
Germany	Lexicon Investigational Site	Berlin
Germany	Lexicon Investigational Site	Essen
Germany	Lexicon Investigational Site	Hamburg
Germany	Lexicon Investigational Site	Marburg
Israel	Lexicon Investigational Site	Jerusalem
Italy	Lexicon Investigational Site	Milano
Italy	Lexicon Investigational Site	Milano
Italy	Lexicon Investigational Site	Pisa
Italy	Lexicon Investigational Site	Torino
Netherlands	Lexicon Investigational Site	Amsterdam
Netherlands	Lexicon Investigational Site	Noord Holland
Netherlands	Lexicon Investigational Site	Noord-Brahant
Spain	Lexicon Investigational Site	Barcelona
Spain	Lexicon Investigational Site	Madrid
Spain	Lexicon Investigational Site	Seville
Sweden	Lexicon Investigational Site	Lund
Sweden	Lexicon Investigational Site	Uppsala
United Kingdom	Lexicon Investigational Site	Coventry
United Kingdom	Lexicon Investigational Site	Glasgow
United Kingdom	Lexicon Investigational Site	London
United Kingdom	Lexicon Investigational Site	London
United Kingdom	Lexicon Investigational Site	London
United Kingdom	Lexicon Investigational Site	Manchester
United Kingdom	Lexicon Investigational Site	Newcastle-Upon-Tyne
United States	Lexicon Investigational Site	Boston	Massachusetts
United States	Lexicon Investigational Site	Iowa City	Iowa
United States	Lexicon Investigational Site	Lexington	Kentucky
United States	Lexicon Investigational Site	Mobile	Alabama
United States	Lexicon Investigational Site	New York	New York
United States	Lexicon Investigational Site	Philadelphia	Pennsylvania
United States	Lexicon Investigational Site	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Israel,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not considered related to the study medication. A TEAE is an AE that occurs or worsens after receiving study drug.	First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)
Secondary	Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit	QLQ-C30 is a standardized 30-item scale to assess health-related quality of life composed of 5 functional scales (physical functioning [5 items], role functioning [2 items], emotional functioning [4 items], cognitive functioning [2 items], and social functioning [2 items]); 3 symptom scales (fatigue [3 items], nausea/vomiting [2 items], and pain [2 items]); a global health status (GHS) /quality of life (QOL) scale [2 items]; 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). 28 questions answered:1 (not at all) to 4 (very much) and 2 questions on overall health/QOL answered:1 (poor) to 7 (excellent). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).	Baseline, Weeks 24, 48, 72 and 84
Secondary	Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit	GI.NET21 is a standardized 21-item scale composed of both multi-item scales and single-item measures that include 5 functional scales (gastrointestinal (GI) [5 items], endocrine [3 items], treatment-related [3 items], social functioning [3 items], and disease-related worries scale [DRWS] [3 items]) and 4 single items (muscle and bone pain symptom (BPS), sexual functioning, communication function (CF), body image and information about the disease). Each item is scored from 1 (not at all) to 4 (very much). All of the scales and single-item measures are transformed to a score of 0 to 100. For functioning scales higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).	Baseline, Weeks 24, 48, 72 and 84
Secondary	Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question	Participants were asked to respond to the following question: "In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort? The percentage of participants reporting adequate relief (answered Yes) were reported.	Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Secondary	Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit	Participants were asked the following question to assess global symptoms associated with carcinoid syndrome (CS) on an 11-point scale: "Rate the severity of your overall carcinoid symptoms over the past 7 days on a scale from 0 to 10, where 0=no symptoms and 10=worst symptoms ever experienced. A negative change from baseline indicated improvement.	Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84