A Phase 2, Open-Label, Multi-Center, Serial Ascending-Dose, Dose-Finding Study to Evaluate the Safety and Tolerability of LX1606 in Subjects With Symptomatic Carcinoid Syndrome
Sponsor study identifier
Secondary identifiers
interventional
15
2 countries
10
Study Start
June 15, 2010
Actual (reported)Primary Completion
February 12, 2014
Actual (reported)Study Completion
February 12, 2014
Actual (reported)The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 12, 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 12, 2010
Actual (reported)April 15, 2010
Actual (reported)June 15, 2010
Actual (reported)February 12, 2014
Actual (reported)February 12, 2014
Actual (reported)April 6, 2018
Actual (reported)Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Core Phase
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Treatment-emergent AEs were defined as any AEs reported after the first dose of treatment on Day 1.
Baseline up to Week 12 in the Core Phase
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Extension Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. Treatment-emergent AEs were defined as any AEs reported after the first dose of treatment on Day 1.
Up to 124 Weeks in the Extension Period
Change From Baseline in Number of Bowel Movements (BMs)
Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Change From Baseline in Stool Form/Consistency
Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Change From Baseline in Percentage of Days With Sensation of Urgency to Defecate
Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Change From Baseline in Sensation/Severity of Nausea Using 100 mm Visual Analog Scale (VAS)
Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24
Number of Participants With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome
Core Phase: Weeks 9-12; Extension Period: Week 24
Following a 2-week Run-In Period, participants received telotristat etiprate capsules at a starting dose of 150 mg, orally three times daily (TID) for 14 days in the Core Phase. Dose escalations (250 mg, 350 mg, 500 mg) occurred serially every 14 days, up to a maximum dosage of telotristat etiprate 500 mg TID, as guided by specific clinical criteria for dose escalation. Upon completion of 12 weeks of treatment, participants were eligible to receive telotristat etiprate in the optional Open-label Extension Period.
Participants received telotristat etiprate at their highest tolerated dose (250 mg or 500 mg), orally, TID for 124 weeks in the Open-label Extension Period. If neither dose was tolerated participants were discontinued from the study and completed the 2-week Follow-up Visit.
Telotristat etiprate capsules orally three times daily.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Lexicon Investigational Site
Bad Berka, Germany
Lexicon Investigational Site
Berlin, Germany
Lexicon Investigational Site
Halle, Germany
Lexicon Investigational Site
Lübeck, Germany
Lexicon Investigational Site
Marburg, Germany
Lexicon Investigational Site
Munich, Germany
Lexicon Investigational Site
Basingstoke, United Kingdom
Pavel M, Horsch D, Caplin M, Ramage J, Seufferlein T, Valle J, Banks P, Lapuerta P, Sands A, Zambrowicz B, Fleming D, Wiedenmann B. Telotristat etiprate for carcinoid syndrome: a single-arm, multicenter trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1511-9. doi: 10.1210/jc.2014-2247. Epub 2015 Jan 30.
Pablo LaPuerta, MD
Lexicon Pharmaceuticals, Inc.
15 participants (actual enrollment reported by the registry).
First Submitted
April 12, 2010
First Posted
April 15, 2010
Study Start
June 15, 2010
Actual (reported)Contact the study team to confirm eligibility.
Lexicon Investigational Site
Cambridge, United Kingdom
Lexicon Investigational Site
London, United Kingdom
Lexicon Investigational Site
Manchester, United Kingdom
Primary Completion
February 12, 2014
Actual (reported)Study Completion
February 12, 2014
Actual (reported)Last Updated
March 15, 2019
Results First Posted
April 6, 2018
Record last verified: 2019-02
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Source: ClinicalTrials.gov.
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