Ignite Creation Date:
2024-05-06 @ 2:27 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02040870
Status:
COMPLETED
Last Update Posted:
2019-02-20
First Post:
2014-01-17
Brief Title:
LDK378 in Adult Chinese Patients With ALK-rearranged ALK-positive Advanced Non-small Cell Lung Cancer NSCLC Previously Treated With Crizotinib
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Multicenter Open-label Single-arm Study of LDK378 Administered Orally in Adult Chinese Patients With ALK-rearranged ALK-positive Advanced Non-small Cell Lung Cancer NSCLC Previously Treated With Crizotinib Study Type Interventional
Status:
COMPLETED
Status Verified Date:
2019-01
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 single-Arm open-label multi-center phase III study in which the pharmacokinetics safety tolerability and efficacy of LDK378 will be assessed in adult Chinese patients with locally advanced or metastatic NSCLC harboring a confirmed ALK rearrangement Patients must have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy Approximately 100 patients will be enrolled For the first 15 patients enrolled in this study patients will have an additional 5-day PK run-in period before treatment period The pharmacokinetics profile of LDK378 in Chinese adult patients with ALK-rearranged NSCLC will be evaluated
Detailed Description:
This is a phase III open-label multi-center study in which the PK safety tolerability and efficacy of LDK378 will be assessed in adult Chinese patients with locally advanced or metastatic NSCLC harboring a confirmed ALK rearrangement positive as assessed using the Vysis ALK Break Apart FISH Probe Kit Abbott Molecular Inc or positive as assessed by immunohistochemistry IHC test Ventana Medical Systems Inc using rabbit monoclonal primary antibody assay D5F3
Patients must have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy
Approximately 100 patients with locally advanced or metastatic NSCLC which carry ALK -rearrangement will be enrolled in the study The first 15 patients to be enrolled in the study will have PK sampling over 120-hour during the 5-day PK run-in period following a single oral dose at 750 mg After the PK run-in period the treatment period will start in which LDK378 will be given starting on Cycle 1 Day 1 in a continuous daily oral dosing in 28-day cycles Separated from these 15 patients the rest of the enrolled patients will receive LDK378 treatment at 750 mg QD on Cycle 1 Day 1
Tumor response will be evaluated every 8 weeks ie every 2 cycles starting from the first day of treatment with LDK378 until the time of RECIST-defined PD by investigator assessment withdrawal of consent for further follow-up loss to follow-up or death
Patients must have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy
Approximately 100 patients with locally advanced or metastatic NSCLC which carry ALK -rearrangement will be enrolled in the study The first 15 patients to be enrolled in the study will have PK sampling over 120-hour during the 5-day PK run-in period following a single oral dose at 750 mg After the PK run-in period the treatment period will start in which LDK378 will be given starting on Cycle 1 Day 1 in a continuous daily oral dosing in 28-day cycles Separated from these 15 patients the rest of the enrolled patients will receive LDK378 treatment at 750 mg QD on Cycle 1 Day 1
Tumor response will be evaluated every 8 weeks ie every 2 cycles starting from the first day of treatment with LDK378 until the time of RECIST-defined PD by investigator assessment withdrawal of consent for further follow-up loss to follow-up or death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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