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)
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
- 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.