A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Crizotinib naive Adult Patients With ALK-activated Non-small Cell Lung Cancer

Trial Profile

A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Crizotinib naive Adult Patients With ALK-activated Non-small Cell Lung Cancer

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 25 Jul 2017

At a glance

  • Drugs Ceritinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Therapeutic Use
  • Acronyms ASCEND III
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 19 Jul 2017 Planned End Date changed from 1 Jun 2017 to 29 Dec 2017.
    • 19 Jul 2017 Planned primary completion date changed from 1 Jun 2017 to 29 Dec 2017.
    • 01 Jun 2017 Results of subgroup analysis 1 (n=330; ceritinib steady-state trough concentration and overall response rate) using patient data from ASCEND-1, ASCEND-2, ASCEND-3 trials and subgroup analysis 2 (n=156; ceritinib single-dose and steady-state AUC0-24h and Cmax) using data from ASCEND-trial assessing impact of PPIs on the PK and efficacy of ceritinib , published in the Cancer Chemotherapy and Pharmacology
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