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Contact Information:

Study Location:

Lexicon Investigational Site
London
NW32QG


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

Completed

Open to: All Genders

Age: 18 Years - N/A

Medical Conditions

Carcinoid Syndrome


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




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.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jan 2013

Mar 2016

Interventional

Intervention Type : Drug
Intervention Description : Telotristat etiprate tablets.

Intervention Arm Group : 250 mg Telotristat Etiprate;500 mg Telotristat Etiprate;Telotristat Etiprate Open-Label Extension

Intervention Type : Drug
Intervention Description : Placebo-matching telotristat etiprate tablets.

Intervention Arm Group : 250 mg Telotristat Etiprate;500 mg Telotristat Etiprate;Placebo;Telotristat Etiprate Open-Label Extension

You can take part if:


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




You may not be able to take part if:

This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Lexicon Investigational Site
    London
    NW32QG
  • Lexicon Investigational Site
    London
    SE59RS
  • Lexicon Investigational Site
    Manchester
    M204BX
  • Lexicon Investigational Site
    London
    W12 OHS
  • Lexicon Investigational Site
    Newcastle upon Tyne
    NE1 4LP
  • Lexicon Investigational Site
    Basingstoke-Hampshire
    RG249NA
  • Lexicon Investigational Site
    Coventry
    CV2 2DX
  • Lexicon Investigational Site
    Glasgow
    G12OYN
  • Lexicon Investigational Site
    Headington-Oxford
    OX37LJ


The study is sponsored by Lexicon Pharmaceuticals



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for Trial ID: NCT01677910

Last updated

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