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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 Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Carcinoid Syndrome
Interventions: Drug: Telotristat etiprate
Drug: Placebo-matching telotristat etiprate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 48 investigative sites in Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, and the United States from 08 January 2013 to 21 March 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with Carcinoid Syndrome not adequately controlled by somatostatin analog (SSA) therapy were assigned in a 1:1:1 ratio to receive placebo, 250 mg or 500 mg telotristat etiprate (LX1606) in the double-blind period and were eligible to receive 500 mg telotristat etiprate in the 36 week open-label extension. 136 randomized;1 patient twice.

Reporting Groups
  Description
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.
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.
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.
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.

Participant Flow for 2 periods

Period 1:   Double-Blind Treatment Period
    Placebo   250 mg Telotristat Etiprate   500 mg Telotristat Etiprate   Telotristat Etiprate Open-Label Extension
STARTED   45   45   45   0 
COMPLETED   38   42   38   0 
NOT COMPLETED   7   3   7   0 
Adverse Event                6                2                3                0 
Physician Decision                0                0                1                0 
Withdrawal of consent                1                0                3                0 
Reason Not Specified                0                1                0                0 

Period 2:   Open-Label Extension Period (OLE)
    Placebo   250 mg Telotristat Etiprate   500 mg Telotristat Etiprate   Telotristat Etiprate Open-Label Extension
STARTED   0   0   0   115 
COMPLETED   0   0   0   79 
NOT COMPLETED   0   0   0   36 
Physician Decision                0                0                0                4 
Reason not Specified                0                0                0                2 
Withdrawal of Consent                0                0                0                9 
Lack of Efficacy                0                0                0                5 
Adverse Event                0                0                0                15 
Lost to Follow-up                0                0                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population

Reporting Groups
  Description
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
   Placebo   250 mg Telotristat Etiprate   500 mg Telotristat Etiprate   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
   63.3  (8.67)   62.4  (9.12)   64.9  (9.06)   63.2  (9.28) 
Age, Customized 
[Units: Participants]
Count of Participants
       
< 65 years         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
< 65 years   25   26   22   73 
≥ 65 years         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
≥ 65 years   20   19   23   62 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Female      21  46.7%      24  53.3%      20  44.4%      65  48.1% 
Male      24  53.3%      21  46.7%      25  55.6%      70  51.9% 
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Hispanic or Latino      0   0.0%      0   0.0%      1   2.2%      1   0.7% 
Not Hispanic or Latino      45 100.0%      44  97.8%      44  97.8%      133  98.5% 
Unknown or Not Reported      0   0.0%      1   2.2%      0   0.0%      1   0.7% 
[1] Ethnicity data was not provided for 1 participant in France.
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
American Indian or Alaska Native      1   2.2%      0   0.0%      0   0.0%      1   0.7% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   2.2%      0   0.0%      0   0.0%      1   0.7% 
White      40  88.9%      41  91.1%      40  88.9%      121  89.6% 
More than one race      0   0.0%      0   0.0%      1   2.2%      1   0.7% 
Unknown or Not Reported      3   6.7%      4   8.9%      4   8.9%      11   8.1% 
[1] Race information was not provided for 11 participants from France.
Region of Enrollment 
[Units: Participants]
       
Canada         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Canada   3   2   2   7 
Sweden         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Sweden   3   3   3   9 
Netherlands         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Netherlands   2   3   3   8 
Belgium         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Belgium   1   0   0   1 
United States         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
United States   12   13   12   37 
United Kingdom         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
United Kingdom   8   3   8   19 
Italy         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Italy   1   4   3   8 
Israel         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Israel   2   0   0   2 
Australia         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Australia   1   2   3   6 
France         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
France   3   4   4   11 
Germany         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Germany   5   8   6   19 
Spain         
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Spain   4   3   1   8 
Somatostatin Analog (SSA) Therapy Schedule at Study Entry [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
3-Week      11  24.4%      11  24.4%      17  37.8%      39  28.9% 
4-Week      34  75.6%      34  75.6%      28  62.2%      96  71.1% 
[1] Patients who were on a 2-week SSA therapy or receiving SSA therapy via a subcutaneous continuous infusion pump are included in the "4-week" category.
SSA Therapy Name at Study Entry 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Octreotide      30  66.7%      40  88.9%      33  73.3%      103  76.3% 
Lanreotide      15  33.3%      5  11.1%      12  26.7%      32  23.7% 
Childbearing Potential 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
Yes      3   6.7%      0   0.0%      0   0.0%      3   2.2% 
No      18  40.0%      24  53.3%      20  44.4%      62  45.9% 
Not Applicable      24  53.3%      21  46.7%      25  55.6%      70  51.9% 
Urinary 5-hydroxyindoleacetic acid (u5-HIAA) at Randomization [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
≤ULN      12  26.7%      12  26.7%      12  26.7%      36  26.7% 
>ULN      26  57.8%      26  57.8%      26  57.8%      78  57.8% 
Unknown      7  15.6%      7  15.6%      7  15.6%      21  15.6% 
[1] ULN=upper limit of normal
Region [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 45   45   45   135 
North America      15  33.3%      15  33.3%      14  31.1%      44  32.6% 
Europe      27  60.0%      28  62.2%      28  62.2%      83  61.5% 
Rest of the World      3   6.7%      2   4.4%      3   6.7%      8   5.9% 
[1] North America includes USA and Canada; Europe includes Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom; Rest of the World includes Australia and Israel.
Weight [1] 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 43   44   44   131 
   70.87  (13.940)   70.05  (14.832)   73.44  (19.971)   71.46  (16.419) 
[1] Weight data was not available for all participants.
Height [1] 
[Units: Centimeter (cm)]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 39   41   40   120 
   168.8  (10.707)   169.32  (9.607)   169.93  (10.436)   169.35  (10.175) 
[1] Height data was not available for all participants.
Body Mass Index (BMI) [1] [2] 
[Units: Kg/m^2]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 38   41   39   118 
   25.13  (4.790)   24.26  (4.702)   25.24  (5.352)   24.87  (4.931) 
[1] BMI was calculated by weight (kg) / (height (cm) *0.01)^2.
[2] Not all participants had weight and height data available to calculate BMI.


  Outcome Measures

1.  Primary:   Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks   [ Time Frame: Baseline and 12 Weeks ]

2.  Primary:   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) ]

3.  Primary:   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) ]

4.  Secondary:   Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points   [ Time Frame: Baseline and 12 Weeks ]

6.  Secondary:   Change From Baseline in Abdominal Pain Averaged Across All Time-Points   [ Time Frame: Baseline and 12 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pablo Lapuerta, MD
Organization: Lexicon Pharmaceuticals, Inc.
e-mail: plapuerta@lexpharma.com



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 Submitted: August 30, 2012
First Posted: September 3, 2012
Results First Submitted: March 29, 2017
Results First Posted: September 18, 2017
Last Update Posted: February 27, 2018