Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01685060
Status:
COMPLETED
Last Update Posted:
2017-06-19
First Post:
2012-09-04
Brief Title:
LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Multicenter Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib
Status:
COMPLETED
Status Verified Date:
2017-05
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 multicenter phase II study Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment discontinued treatment at the discretion of the investigator or patient started a new anti-cancer therapy andor died LDK378 could be 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 In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2012-003432-24 | EUDRACT_NUMBER | None | None |