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A Phase I, Multi-center, Open Label Dose Escalation Study of LDK378, Administered Orally in Adult Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)

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Trial Profile

A Phase I, Multi-center, Open Label Dose Escalation Study of LDK378, Administered Orally in Adult Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Ceritinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ASCEND-I
  • Sponsors Novartis

Most Recent Events

  • 18 Oct 2017 Results of a sub-group analysis assessing safety and efficacy of ceritinib in patients who were pretreated with crizotinib only (Data cut-off: May 03, 2016; n=26) presented at the 18th World Conference on Lung Cancer
  • 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

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