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A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Varlitinib Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer as Second Line Systemic Therapy

Trial Profile

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Varlitinib Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Advanced or Metastatic Biliary Tract Cancer as Second Line Systemic Therapy

Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 04 Jan 2019

At a glance

  • Drugs Varlitinib (Primary) ; Capecitabine
  • Indications Adenocarcinoma; Biliary cancer; Carcinoma; Cholangiocarcinoma; Gallbladder cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms TreeTopp
  • Sponsors ASLAN Pharmaceuticals
  • Most Recent Events

    • 02 Jan 2019 According to an ASLAN Pharmaceuticals media release, this trial will meet its primary objective if either endpoint is significant at the one-sided 5% level or if both endpoints are significant at the one-sided 10% significance level. If the study results are positive, ASLAN intends to submit a New Drug Application to the US Food and Drug Administration (FDA) for an accelerated approval in second-line BTC.
    • 02 Jan 2019 According to a ASLAN Pharmaceuticals media release, this study completed patient enrolment ahead of schedule for Part 1 of study (Phase 2, n=127).Topline data from this study is expected in the second half of 2019.
    • 29 Dec 2018 Part 2 of this study (Phase 3) has not yet started recruitment.
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