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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

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 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


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.




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.



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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

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


  Hide Study Locations
Locations
United States, Alabama
Lexicon Investigational Site
Mobile, Alabama, United States, 36604
United States, California
Lexicon Investigational Site
Palo Alto, California, United States, 94305
Lexicon Investigational Site
San Francisco, California, United States, 94115
United States, Florida
Lexicon Investigational Site
Orlando, Florida, United States, 32806
United States, Iowa
Lexicon Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
Lexicon Investigational Site
Lexington, Kentucky, United States, 40536
United States, Louisiana
Lexicon Investigational Site
Kenner, Louisiana, United States, 70065
United States, Massachusetts
Lexicon Investigational Site
Boston, Massachusetts, United States, 02114
Lexicon Investigational Site
Boston, Massachusetts, United States, 02215
United States, Nebraska
Lexicon Investigational Site
Omaha, Nebraska, United States, 68114
United States, New York
Lexicon Investigational Site
Buffalo, New York, United States, 14263
Lexicon Investigational Site
New York, New York, United States, 10029
United States, North Carolina
Lexicon Investigational Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Lexicon Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Lexicon Investigational Site
Fort Worth, Texas, United States, 76104
Lexicon Investigational Site
Houston, Texas, United States, 77030
Lexicon Investigational Site
McAllen, Texas, United States, 78503
Australia, New South Wales
Lexicon Investigational Site
Kogara, New South Wales, Australia, 2217
Lexicon Investigational Site
Saint Leanoards, New South Wales, Australia, 2065
Australia, Queensland
Lexicon Investigational Site
Herston, Queensland, Australia, 4029
Australia, Victoria
Lexicon Investigational Site
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Lexicon Investigational Site
Freemantle, Western Australia, Australia, 6160
Australia
Lexicon Investigational Site
Woodville South, Australia, 5011
Belgium
Lexicon Investigational Site
Edegem, Belgium, B-2650
Lexicon Investigational Site
Gent, Belgium, 9000
Lexicon Investigational Site
Yvoir, Belgium, B-5530
Canada, Alberta
Lexicon Investigational Site
Calgary, Alberta, Canada, T2N 4N2
Canada, Nova Scotia
Lexicon Investigational Site
Halifax, Nova Scotia, Canada, B3H2Y9
France
Lexicon Investigational Site
Clichy, France, 92118
Lexicon Investigational Site
Lille, France, 59037
Lexicon Investigational Site
Lyon, France, 69437
Lexicon Investigational Site
Marseille, France, 13385
Lexicon Investigational Site
Strasbourg, France, 67098
Lexicon Investigational Site
Villejuif, France, 94805
Germany
Lexicon Investigational Site
Bad Berka, Germany, 99437
Lexicon Investigational Site
Berlin, Germany, 13353
Lexicon Investigational Site
Essen, Germany, 45147
Lexicon Investigational Site
Hamburg, Germany, 20246
Lexicon Investigational Site
Heidelberg, Germany, 69120
Lexicon Investigational Site
Lubeck, Germany, 23538
Lexicon Investigational Site
Mainz, Germany, 55131
Lexicon Investigational Site
Marburg, Germany, 35043
Lexicon Investigational Site
Munchen, Germany, 81377
Lexicon Investigational Site
Neuss, Germany, 41464
Israel
Lexicon Invetigational Site
Jerusalem, Israel, 91120
Italy
Lexicon Investigational Site
Bologna, Italy, 40138
Lexicon Investigational Site
Ferrara, Italy, 44124
Lexicon Investigational Site
Milan, Italy, 20089
Lexicon Investigational Site
Milan, Italy, 20141
Lexicon Investigational Site
Modena, Italy, 41126
Lexicon Investigational Site
Napoli, Italy, 80100
Lexicon Investigational Site
Orbassano, Italy, 10043
Lexicon Investigational Site
Perugia, Italy, 06156
Lexicon Investigational Site
Pisa, Italy, 56124
Lexicon Investigational Site
Rome, Italy, 00189
Netherlands
Lexicon Investigational Site
Amsterdam, Netherlands, 1105 AZ
Lexicon Investigational Site
Noord-Brahant, Netherlands, 5631BM
Lexicon Investigational Site
Noord-Holland, Netherlands, 1066CX
Lexicon Investigational Site
Zuid-Holland, Netherlands, 3015E
Spain
Lexicon Investigational Site
Barcelona, Spain, 08035
Lexicon Investigational Site
Barcelona, Spain, 08907
Lexicon Investigational Site
Madrid, Spain, 28034
Lexicon Investigational Site
Madrid, Spain, 28040
Lexicon Investigational Site
Seville, Spain, 41013
Sweden
Lexicon Investigational Site
Lund, Sweden, 22185
Lexicon Investigational Site
Uppsala, Sweden, 75185
United Kingdom
Lexicon Investigational Site
Basingstoke-Hampshire, United Kingdom, RG249NA
Lexicon Investigational Site
Coventry, United Kingdom, CV2 2DX
Lexicon Investigational Site
Glasgow, United Kingdom, G12OYN
Lexicon Investigational Site
Headington-Oxford, United Kingdom, OX37LJ
Lexicon Investigational Site
London, United Kingdom, NW32QG
Lexicon Investigational Site
London, United Kingdom, SE59RS
Lexicon Investigational Site
London, United Kingdom, W12 OHS
Lexicon Investigational Site
Manchester, United Kingdom, M204BX
Lexicon Investigational Site
Newcastle upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Pablo Lapuerta, MD Lexicon Pharmaceuticals, Inc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01677910     History of Changes
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:
Syndrome
Carcinoid Tumor
Malignant Carcinoid 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
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs