drugset / Trial / NCT02299505
Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)
RandomizedParallel-groupOpen-labelTreatment
Summary
A Phase I study to assess the systemic exposure, effiacy, 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)
Timeline
- Start
- 2015-04-09
- Primary completion
- 2016-06-16
- Completion
- 2020-03-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceritinib | Small molecule | 450 mg | Oral |
| Subject | Ceritinib | Small molecule | 600 mg | Oral |
| Subject | Ceritinib | Small molecule | 750 mg | Oral |