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

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ClinicalTrials.gov Identifier: NCT01677910
Recruitment Status : Completed
First Posted : September 3, 2012
Results First Posted : September 18, 2017
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 30, 2012
First Posted Date  ICMJE September 3, 2012
Results First Submitted Date  ICMJE March 29, 2017
Results First Posted Date  ICMJE September 18, 2017
Last Update Posted Date February 27, 2018
Actual Study Start Date  ICMJE January 8, 2013
Actual Primary Completion Date March 21, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks [ Time Frame: Baseline and 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.
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period [ Time Frame: 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) ]
    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.
  • Number of Participants With TEAEs in the Open-Label Extension Period [ Time Frame: 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) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2012)
Change From Baseline in Number of Daily Bowel Movements [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT01677910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels [ Time Frame: Baseline and Week 12 ]
    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.
  • Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points [ Time Frame: Baseline and 12 Weeks ]
    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.
  • Change From Baseline in Abdominal Pain Averaged Across All Time-Points [ Time Frame: Baseline and 12 Weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2012)
  • Change from baseline in stool consistency [ Time Frame: 12 weeks ]
  • Change From Baseline in the Number of Cutaneous Flushing Episodes [ Time Frame: 12 weeks ]
  • Change From Baseline in Abdominal Pain [ Time Frame: 12 weeks ]
  • Change in the frequency of rescue short-acting somatostatin analog [ Time Frame: 12 weeks ]
  • Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants were randomized to one of three treatment arms in the double-blind treatment period. After completion of the double-blind treatment period, participants entered an open-label treatment period.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Carcinoid Syndrome
Intervention  ICMJE
  • Drug: Telotristat etiprate
    Telotristat etiprate tablets.
    Other Name: LX1606
  • Drug: Placebo-matching telotristat etiprate
    Placebo-matching telotristat etiprate tablets.
Study Arms  ICMJE
  • Experimental: 250 mg Telotristat Etiprate
    Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
    Interventions:
    • Drug: Telotristat etiprate
    • Drug: Placebo-matching telotristat etiprate
  • Experimental: 500 mg Telotristat Etiprate
    Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
    Interventions:
    • Drug: Telotristat etiprate
    • Drug: Placebo-matching telotristat etiprate
  • Placebo Comparator: Placebo
    Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.
    Intervention: Drug: Placebo-matching telotristat etiprate
  • Experimental: Telotristat Etiprate Open-Label Extension
    Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.
    Interventions:
    • Drug: Telotristat etiprate
    • Drug: Placebo-matching telotristat etiprate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2016)
135
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2012)
105
Actual Study Completion Date  ICMJE March 21, 2016
Actual Primary Completion Date March 21, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Israel,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01677910
Other Study ID Numbers  ICMJE LX1606.1-301-CS
LX1606.301 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
2012-003460-47 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lexicon Pharmaceuticals
Study Sponsor  ICMJE Lexicon Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pablo Lapuerta, MD Lexicon Pharmaceuticals, Inc
PRS Account Lexicon Pharmaceuticals
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP