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)

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)

Completed
Phase of Trial: Phase I

Latest Information Update: 06 Jun 2017

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

    • 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
    • 07 Dec 2016 Results of whole body and intracranial activity data from two studies ( ASCEND-1 and ASCEND-3) presented at the 17th World Conference on Lung Cancer
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