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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoid Syndrome Drug: Telotristat etiprate Drug: Placebo-matching telotristat etiprate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
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
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
Actual Study Start Date : January 8, 2013
Actual Primary Completion Date : March 21, 2016
Actual Study Completion Date : March 21, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Carcinoid Tumors

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Telotristat etiprate
Telotristat etiprate tablets.
Other Name: LX1606

Drug: Placebo-matching telotristat etiprate
Placebo-matching telotristat etiprate tablets.
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.
 Drug: Telotristat etiprate
Telotristat etiprate tablets.
Other Name: LX1606

Drug: Placebo-matching telotristat etiprate
Placebo-matching telotristat etiprate tablets.
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.
 Drug: Placebo-matching telotristat etiprate
Placebo-matching telotristat etiprate tablets.
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.
 Drug: Telotristat etiprate
Telotristat etiprate tablets.
Other Name: LX1606

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677910


Locations
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Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Pablo Lapuerta, MD Lexicon Pharmaceuticals, Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01677910    
Other Study ID Numbers: LX1606.1-301-CS
LX1606.301 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
2012-003460-47 ( EudraCT Number )
First Posted: September 3, 2012    Key Record Dates
Results First Posted: September 18, 2017
Last Update Posted: February 27, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Carcinoid Tumor
Malignant Carcinoid Syndrome
Syndrome
Serotonin Syndrome
Disease
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders