LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01685060 |
Recruitment Status :
Completed
First Posted : September 13, 2012
Results First Posted : May 8, 2017
Last Update Posted : June 19, 2017
|
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Non-Small Cell Lung Cancer |
Intervention |
Drug: LDK378 |
Enrollment | 140 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Approximately 137 patients were planned to be enrolled. A total of 140 patients were enrolled and treated with ceritinib. |
Arm/Group Title | LDK378 750mg |
---|---|
![]() |
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted. |
Period Title: Overall Study | |
Started | 140 |
Entered Post-treatment Efficacy f/u | 7 |
Entered Survival Follow up | 98 |
Discontinued From Study | 35 |
Completed | 0 |
Not Completed | 140 |
Reason Not Completed | |
Rollover patients | 16 |
Adverse Event | 12 |
Progressive disease | 69 |
Physician Decision | 14 |
Subject/guardian decision | 20 |
Lost to Follow-up | 1 |
Death | 8 |
Baseline Characteristics
Arm/Group Title | LDK378 750mg | |
---|---|---|
![]() |
Patients treated with ceritinib/LDK378 750 mg once-daily, fasted. | |
Overall Number of Baseline Participants | 140 | |
![]() |
Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||
Number Analyzed | 140 participants | |
51.2 (11.62) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 140 participants | |
Female |
70 50.0%
|
|
Male |
70 50.0%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety
Results Point of Contact
Name/Title: | Study Director |
Organization: | Novartis Pharmaceuticals |
Phone: | 862-778-8300 |
EMail: | trialandresults.registries@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
ClinicalTrials.gov Identifier: | NCT01685060 |
Other Study ID Numbers: |
CLDK378A2201 2012-003432-24 ( EudraCT Number ) |
First Submitted: | September 4, 2012 |
First Posted: | September 13, 2012 |
Results First Submitted: | March 27, 2017 |
Results First Posted: | May 8, 2017 |
Last Update Posted: | June 19, 2017 |