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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jul 2017

At a glance

  • Drugs Telotristat etiprate (Primary)
  • Indications Malignant carcinoid syndrome
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms TELESTAR
  • Sponsors Lexicon Pharmaceuticals
  • Most Recent Events

    • 21 Jul 2017 According to an Ipsen media release, based on the results from TELESTAR and TELECAST studies the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the approval of Xermelo (telotristat ethyl) 250 mg three times a day for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue therapy in adults inadequately controlled by SSA therapy.
    • 10 Jun 2017 Biomarkers information updated
    • 06 Jun 2017 Results of prespecified analysis of the incidence of weight change of more than 3 % at week 12, presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
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