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

Trial Profile

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

Completed
Phase of Trial: Phase II

Latest Information Update: 06 Jun 2017

At a glance

  • Drugs Ceritinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Therapeutic Use
  • Acronyms ASCEND-2
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 06 Jun 2017 Results of analysis assessing use of MAIC to indirectly compare progression-free survival (PFS) and overall survival (OS) using patient data from ALTA, ASCEND I, ASCEND 2 and NP28673 trials, presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
    • 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
    • 06 Dec 2016 Results of Population Pharmacokinetic Analysis of Ceritinib from 4 trials (ASCEND-I, CLDK378X1101, ASCEND-II and ASCEND-III; n=581) published in the Journal of Clinical Pharmacology
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