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A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC)

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Trial Profile

A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 29 Feb 2024

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At a glance

  • Drugs Cisplatin (Primary) ; Gemcitabine (Primary) ; Telotristat etiprate (Primary)
  • Indications Biliary cancer; Cholangiocarcinoma; Gallbladder cancer
  • Focus Therapeutic Use
  • Acronyms TELE-ABC
  • Sponsors Lexicon Pharmaceuticals; TerSera Therapeutics

Most Recent Events

  • 20 Jan 2024 Primary endpoint (Progression free survival (PFS) rate according to RECIST 1.1. at Month 6) has not been met, according to results presented at the 2024 Gastrointestinal Cancers Symposium
  • 20 Jan 2024 Results assessing the safety and efficacy of adding TE to GC chemotherapy in pts with advanced Biliary Tract Cancer. presented at the 2024 Gastrointestinal Cancers Symposium
  • 25 Jan 2023 This study protocol has been amended as primary end point (Incidence of treatment emergent adverse events) has been removed and primary endpoint (Overall Survival) has been added. Hence, the focus has been shifted to Tu only.

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