Ignite Creation Date:
2024-05-06 @ 3:26 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02299505
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2014-11-14
Brief Title:
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
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Multi-center Randomized Open Label 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
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This was an open-label randomized multi-center parallel design Phase I study in which the systemic exposure efficacy and safety of ceritinib administered at 450 mg or 600 mg with a low-fat meal vs 750 mg in the fasted state was assessed in subjects with ALK NSCLC following multiple oral daily dosing of ceritinib Subjects were randomized in a 111 ratio to once daily doses of oral ceritinib 450 mg following a low-fat meal 600 mg following a low-fat meal or ceritinib 750 mg administered on an empty stomach Randomization was stratified by brain metastases at Screening presence or absence and by prior treatment prior crizotinib use with ALK determined by Fluorescent in situ hybridization FISH crizotinib-naïve but could be previously treated with other systemic anti-cancer therapy with ALK determined by FISH or treatment-naïve subjects with ALK by IHC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-004001-32 | EUDRACT_NUMBER | None | None |