Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

NCT02026063 | Completed Phase 3 Results DMC

• 3 other identifiers: LX1606.1-302-CSLX1606.3022013-002596-18
• Study Type: interventional
• Target: 124
• Locations: 12 countries
• Sites: 43

Brief Summary

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

Conditions

Carcinoid Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit

  Baseline, Weeks 24, 48, 72 and 84

• Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit

  Baseline, Weeks 24, 48, 72 and 84

• Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question

  Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84

• Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit

  Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84

Study Arms (2)

250 mg Telotristat Etiprate

EXPERIMENTAL

One telotristat etiprate (250 mg) tablet administered three times daily.

Drug: Telotristat etiprate

500 mg Telotristat Etiprate

EXPERIMENTAL

Two telotristat etiprate (250 mg) tablets administered three times daily.

Drug: Telotristat etiprate

Interventions

Telotristat etiprate DRUG

Telotristat etiprate tablet (250 mg)

Also known as: LX1606

250 mg Telotristat Etiprate; 500 mg Telotristat Etiprate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (43)

Lexicon Investigational Site

Mobile, Alabama, 36604, United States

Location

Lexicon Investigational Site

Stanford, California, 94305, United States

Location

Lexicon Investigational Site

Iowa City, Iowa, 52242, United States

Location

Lexicon Investigational Site

Lexington, Kentucky, 40536, United States

Location

Lexicon Investigational Site

Boston, Massachusetts, 02215, United States

Location

Lexicon Investigational Site

New York, New York, 10029, United States

Location

Lexicon Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Lexicon Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

Lexicon Investigational Site

Herston, Queensland, 4029, Australia

Location

Lexicon Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

Lexicon Investigational Site

Edegem, B-2650, Belgium

Location

Lexicon Investigational Site

Ghent, 9000, Belgium

Location

Lexicon Investigational Site

Yvoir, 5530, Belgium

Location

Lexicon Investgational Site

Calgary, Alberta, T2N4N2, Canada

Location

Lexicon Investigational Site

Halifax, Nova Scotia, B0J1N0, Canada

Location

Lexicon Investigational Site

Lille, 59037, France

Location

Lexicon Investigational Site

Lyon, 69437, France

Location

Lexicon Investigational Site

Villejuif, 94805, France

Location

Lexicon Investigational Site

Bad Berka, 99437, Germany

Location

Lexicon Investigational Site

Berlin, 13353, Germany

Location

Lexicon Investigational Site

Essen, 45147, Germany

Location

Lexicon Investigational Site

Hamburg, 20246, Germany

Location

Lexicon Investigational Site

Marburg, 35043, Germany

Location

Lexicon Investigational Site

Jerusalem, 91120, Israel

Location

Lexicon Investigational Site

Milan, 20089, Italy

Location

Lexicon Investigational Site

Milan, 20141, Italy

Location

Lexicon Investigational Site

Pisa, 56124, Italy

Location

Lexicon Investigational Site

Torino, 10043, Italy

Location

Lexicon Investigational Site

Amsterdam, 1105AZ, Netherlands

Location

Lexicon Investigational Site

Noord Holland, 1066CX, Netherlands

Location

Lexicon Investigational Site

Noord-Brahant, 5631BM, Netherlands

Location

Lexicon Investigational Site

Barcelona, 08035, Spain

Location

Lexicon Investigational Site

Madrid, 28034, Spain

Location

Lexicon Investigational Site

Seville, 41013, Spain

Location

Lexicon Investigational Site

Lund, 22185, Sweden

Location

Lexicon Investigational Site

Uppsala, 75185, Sweden

Location

Lexicon Investigational Site

Coventry, CV22DX, United Kingdom

Location

Lexicon Investigational Site

Glasgow, G120YN, United Kingdom

Location

Lexicon Investigational Site

London, NW32QG, United Kingdom

Location

Lexicon Investigational Site

London, SE59RS, United Kingdom

Location

Lexicon Investigational Site

London, W120HS, United Kingdom

Location

Lexicon Investigational Site

Manchester, M204BX, United Kingdom

Location

Lexicon Investigational Site

Newcastle upon Tyne, NE14LP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33940581 DERIVED

MeSH Terms

Conditions

Serotonin Syndrome

Interventions

telotristat

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Results Point of Contact

• Title: Pablo Lapuerta, MD
• Organization: Lexicon Pharmaceuticals, Inc.

plapuerta@lexpharma.com

281-863-3000

Study Officials

• Pablo Lapuerta, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2013
• First Posted: January 1, 2014
• Study Start: January 14, 2014
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: September 17, 2019
• Results First Posted: September 17, 2019

Record last verified: 2019-08

Locations

ES (3); BE (3); DE (5); CA (2); SE (2); IT (4); GB (7); US (7); NL (3); IL (1); AU (3); FR (3)