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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01677910
First Posted: September 3, 2012
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
August 30, 2012
September 3, 2012
March 29, 2017
September 18, 2017
September 18, 2017
October 2012
March 2016   (Final data collection date for primary outcome measure)
  • Change From Baseline in Number of Daily Bowel Movements [ Time Frame: Baseline and 12 weeks ]
  • Number of Participants With Treatment-emergent Adverse Events [ Time Frame: 12 weeks ]
Change From Baseline in Number of Daily Bowel Movements [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT01677910 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (5-HIAA) Levels [ Time Frame: Baseline and 12 weeks ]
  • Change From Baseline in the Number of Cutaneous Flushing Episodes [ Time Frame: Baseline and 12 weeks ]
  • Change From Baseline in Abdominal Pain [ Time Frame: Baseline and 12 weeks ]
    To assess sensation/severity of nausea on a daily basis, patients recorded their response using a 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe.
  • 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 ]
Not Provided
Not Provided
 
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carcinoid Syndrome
  • Drug: Telotristat etiprate tablets (250 mg)
    Other Name: LX1606
  • Drug: Placebo tablets
    One placebo tablet administered three times daily
  • Experimental: 250 mg telotristat etiprate
    One telotristat etiprate (250 mg) tablet administered three times daily
    Intervention: Drug: Telotristat etiprate tablets (250 mg)
  • Experimental: 500 mg telotristat etiprate
    Two telotristat etiprate (250 mg) tablets administered three times daily
    Intervention: Drug: Telotristat etiprate tablets (250 mg)
  • Placebo Comparator: Placebo
    Placebo administered three times daily
    Intervention: Drug: Placebo tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
March 2016
March 2016   (Final data collection date for primary outcome measure)

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 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, 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, or QTcF >450 ms
  • Previous exposure to telotristat etiprate
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   France,   Germany,   Israel,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT01677910
LX1606.1-301-CS
LX1606.301 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
Yes
Not Provided
Not Provided
Lexicon Pharmaceuticals
Lexicon Pharmaceuticals
Not Provided
Study Director: Pablo Lapuerta, MD Lexicon Pharmaceuticals, Inc
Lexicon Pharmaceuticals
August 2017

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