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)

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)

Recruiting
Phase of Trial: Phase I

Latest Information Update: 09 Oct 2017

At a glance

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

    • 17 Jul 2017 Results of part 1 of this study (n=137; as off 16 Jun 2016) published in the Journal of Thoracic Oncology.
    • 01 Mar 2017 Planned number of patients changed from 300 to 318.
    • 01 Mar 2017 Planned End Date changed from 1 Jan 2018 to 25 Oct 2018.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top