TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

Carcinoid Syndrome Clinical Trial

Official title:

A Phase 3, Randomized, Placebo-controlled, Parallel Group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog (SSA) Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677910
• Other study ID #: LX1606.1-301-CS
• Secondary ID: LX1606.3012012-0
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2012
• Last updated: January 26, 2018
• Start date: January 8, 2013
• Est. completion date: March 21, 2016

Study information

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

Clinical Trial Summary

The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 21, 2016
• Est. primary completion date: March 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor

• Documented history of carcinoid syndrome and currently experiencing =4 bowel movements per day during the Run-in period

• Currently receiving stable-dose somatostatin analog (SSA) therapy

• Minimum dose of long-acting release (LAR) or depot SSA therapy

• Octreotide LAR at 30 mg every 4 weeks

• Lanreotide Depot at 120 mg every 4 weeks

• Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose

• Ability and willingness to provide written informed consent

Exclusion Criteria:

• Presence of diarrhea attributed to any condition(s) other than carcinoid syndrome

• Karnofsky Performance status =60%

• Treatment with any tumor directed therapy, including interferon, chemotherapy, mechanistic target of rapamycin (mTOR) inhibitors <4 weeks prior to Screening, or hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking <12 weeks prior to Screening

• History of short bowel syndrome (SBS)

• Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study

• Previous exposure to telotristat etiprate

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Australia	Lexicon Investigational Site	Fitzroy	Victoria
Australia	Lexicon Investigational Site	Freemantle	Western Australia
Australia	Lexicon Investigational Site	Herston	Queensland
Australia	Lexicon Investigational Site	Kogara	New South Wales
Australia	Lexicon Investigational Site	Saint Leanoards	New South Wales
Australia	Lexicon Investigational Site	Woodville South
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	Essen
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	Munchen
Germany	Lexicon Investigational Site	Neuss
Israel	Lexicon Invetigational Site	Jerusalem
Italy	Lexicon Investigational Site	Bologna
Italy	Lexicon Investigational Site	Ferrara
Italy	Lexicon Investigational Site	Milan
Italy	Lexicon Investigational Site	Milan
Italy	Lexicon Investigational Site	Modena
Italy	Lexicon Investigational Site	Napoli
Italy	Lexicon Investigational Site	Orbassano
Italy	Lexicon Investigational Site	Perugia
Italy	Lexicon Investigational Site	Pisa
Italy	Lexicon Investigational Site	Rome
Netherlands	Lexicon Investigational Site	Amsterdam
Netherlands	Lexicon Investigational Site	Noord-Brahant
Netherlands	Lexicon Investigational Site	Noord-Holland
Netherlands	Lexicon Investigational Site	Zuid-Holland
Spain	Lexicon Investigational Site	Barcelona
Spain	Lexicon Investigational Site	Barcelona
Spain	Lexicon Investigational Site	Madrid
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	Basingstoke-Hampshire
United Kingdom	Lexicon Investigational Site	Coventry
United Kingdom	Lexicon Investigational Site	Glasgow
United Kingdom	Lexicon Investigational Site	Headington-Oxford
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	Boston	Massachusetts
United States	Lexicon Investigational Site	Buffalo	New York
United States	Lexicon Investigational Site	Durham	North Carolina
United States	Lexicon Investigational Site	Fort Worth	Texas
United States	Lexicon Investigational Site	Houston	Texas
United States	Lexicon Investigational Site	Iowa City	Iowa
United States	Lexicon Investigational Site	Kenner	Louisiana
United States	Lexicon Investigational Site	Lexington	Kentucky
United States	Lexicon Investigational Site	McAllen	Texas
United States	Lexicon Investigational Site	Mobile	Alabama
United States	Lexicon Investigational Site	New York	New York
United States	Lexicon Investigational Site	Omaha	Nebraska
United States	Lexicon Investigational Site	Orlando	Florida
United States	Lexicon Investigational Site	Palo Alto	California
United States	Lexicon Investigational Site	Philadelphia	Pennsylvania
United States	Lexicon Investigational Site	San Francisco	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	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
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 17.6 Weeks)
Primary	Number of Participants With 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 54.3 Weeks)
Secondary	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 Week 12
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