Ignite Creation Date:
2024-05-06 @ 12:54 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01685138
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2012-09-04
Brief Title:
LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Multicenter Single-arm Study of Oral LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2019-03
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 two-stage multicenter phase II study Patients were pre-screened for ALK positive status Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment discontinued treatment at the discretion of the investigator or patient started a new anticancer therapy andor died LDK378 was continued beyond RECIST defined progressive disease PD as assessed by the investigator if in the judgment of the investigator there was evidence of clinical benefit Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer NSCLC were screened for eligibility Patients had to have received no prior crizotinib and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy up to three prior lines
Detailed Description:
None
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 |
|---|---|---|---|
| 2012-003474-36 | EUDRACT_NUMBER | None | None |