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A Phase I, Multi-center, Randomized Open Label Study to Assess the Systemic Exposure and Safety of 450 mg Ceritinib Taken With a Low-fat Meal and 600 mg Ceritinib Taken With a Low-fat Meal as Compared With That of 750 mg Ceritinib Taken in the Fasted State in Adult Patients With ALK Rearranged (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

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Trial Profile

A Phase I, Multi-center, Randomized Open Label Study to Assess the Systemic Exposure and Safety of 450 mg Ceritinib Taken With a Low-fat Meal and 600 mg Ceritinib Taken With a Low-fat Meal as Compared With That of 750 mg Ceritinib Taken in the Fasted State in Adult Patients With ALK Rearranged (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Ceritinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Pharmacokinetics
  • Acronyms ASCEND-8
  • Sponsors Novartis; Novartis Pharmaceuticals

    • Most Recent Events

    • 31 Jan 2021 Results of final analysis presented at the 2020 World Conference on Lung Cancer
    • 21 Sep 2020 Results (data cut-off : March 6, 2020; n=198) from Asian patients presented at the 45th European Society for Medical Oncology Congress
    • 24 Mar 2020 Status changed from active, no longer recruiting to completed.
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