Telotristat Etiprate for Carcinoid Syndrome Therapy

Carcinoid Syndrome Clinical Trial

— TELECAST  

Official title:

A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063659
• Other study ID #: LX1606.1-303-CS
• Secondary ID: LX1606.3032013-0
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2014
• Last updated: January 26, 2018
• Start date: March 11, 2014
• Est. completion date: March 29, 2016

Study information

• Verified date: January 2018
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 29, 2016
• Est. primary completion date: March 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 18 years of age

• All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit.

• Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor

• Documented history of carcinoid syndrome

• Patient is able and willing to provide written informed consent prior to participation

Exclusion Criteria:

• Presence of diarrhea attributed to any condition other than carcinoid syndrome.

• Presence of 12 or more watery bowel movements per day

• Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening

• Karnofsky Performance Status = 60%

• Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator

• A history of short bowel syndrome

• History of constipation within 2 years of Screening

• Life expectancy < 12 months from Screening

Related Conditions & MeSH terms

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

Intervention

Drug:
• Telotristat etiprate
Telotristat etiprate tablets
• Placebo
Placebo-matching telotristat etiprate tablets

Locations

Country	Name	City	State
Australia	Lexicon Investigational Site	East Melbourne	Victoria
Australia	Lexicon Investigational Site	Herston	Queensland
Australia	Lexicon Investigational Site	Kogara	New South Wales
Australia	Lexicon Investigational Site	St. Leonards	New South Wales
Belgium	Lexicon Investigational Site	Edegem
Belgium	Lexicon Investigational Site	Gent
Belgium	Lexicon Investigational Site	Yvoir
Canada	Lexicon Investigational Site	Calgary	Alberta
Canada	Lexicon Investigational Site	Halifax	Nova Scotia
France	Lexicon Investigational Site	Clichy
France	Lexicon Investigational Site	Lille
France	Lexicon Investigational Site	Lyon
France	Lexicon Investigational Site	Marseille
France	Lexicon Investigational Site	Strasbourg
France	Lexicon Investigational Site	Villejuif
Germany	Lexicon Investigational Site	Bad Berka
Germany	Lexicon Investigational Site	Berlin
Germany	Lexicon Investigational Site	Hamburg
Germany	Lexicon Investigational Site	Heidelberg
Germany	Lexicon Investigational Site	Lubeck
Germany	Lexicon Investigational Site	Mainz
Germany	Lexicon Investigational Site	Marburg
Germany	Lexicon Investigational Site	Munich
Germany	Lexicon Investigational Site	Neuss
Israel	Lexicon Investigational Site	Jerusalem
Netherlands	Lexicon Investigational Site	Amsterdam	Noord-Holland
Netherlands	Lexicon Investigational Site	Amsterdam	Noord-Holland
Netherlands	Lexicon Investigational Site	Noord Brahant
Netherlands	Lexicon Investigative Site	Rotterdam
Spain	Lexicon Investigational Site	Barcelona
Spain	Lexicon Investigational Site	Barcelona
Spain	Lexicon Investigational Site	Madrid
Spain	Lexicon Investigational Site	Madrid
Spain	Lexicon Investigational Site	Sevilla
Sweden	Lexicon Investigational Site	Uppsala
United Kingdom	Lexicon Investigational Site	Basingstoke Hampshire
United Kingdom	Lexicon Investigational Site	Coventry
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	Buffalo	New York
United States	Lexicon Investigational Site	Iowa City	Iowa
United States	Lexicon Investigational Site	Lexington	Kentucky
United States	Lexicon Investigational Site	New York	New York
United States	Lexicon Investigational Site	Orlando	Florida
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,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment 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. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.	First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.1 Weeks)
Primary	Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels	u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.	Baseline and 12 Weeks
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label 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. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.	First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 52.6 Weeks)
Secondary	Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks	Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.	Baseline and 12 weeks
Secondary	Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points	Participants assessed stool form/consistency of a BM using the Bristol Stool Form Scale where: 1=hard lumps to 7=watery liquid. The daily scores were averaged over the 12-week period. A negative change indicates improvement.	Baseline and 12 Weeks
Secondary	Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points	Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.	Baseline and 12 Weeks
Secondary	Change From Baseline in Abdominal Pain Averaged Across All Time-Points	Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.	Baseline and 12 Weeks
Secondary	Change in the Frequency of Rescue Short-acting, Somatostatin Analog (SSA) Used to Treat Carcinoid Syndrome Symptoms Averaged Across All Time-Points	The frequency (the number of times) the participant used rescue with SSA to control symptoms was recorded in a daily diary. The daily number of rescue treatments with SSA was averaged over the 12- week period. A negative change from Baseline (less use of SSA) indicates improvement.	Baseline and 12 weeks
Secondary	Change From Baseline in the Number of Daily BMs Averaged Over the 12-Week Double-Blind Period, Among Participants Who Were Not Receiving SSA Therapy at Baseline	Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.	Baseline and 12 Weeks