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LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01685060
First Posted: September 13, 2012
Last Update Posted: June 19, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: March 27, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Intervention: Drug: LDK378

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Approximately 137 patients were planned to be enrolled. A total of 140 patients were enrolled and treated with ceritinib.

Reporting Groups
  Description
LDK378 750mg Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.

Participant Flow:   Overall Study
    LDK378 750mg
STARTED   140 
Entered Post-treatment Efficacy f/u   7 
Entered Survival Follow up   98 
Discontinued From Study   35 
COMPLETED   0 
NOT COMPLETED   140 
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.

Reporting Groups
  Description
LDK378 750mg Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.

Baseline Measures
   LDK378 750mg 
Overall Participants Analyzed 
[Units: Participants]
 140 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.2  (11.62) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      70  50.0% 
Male      70  50.0% 


  Outcome Measures
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1.  Primary:   Overall Response Rate (ORR) to LDK378 Per Investigator Assessment   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]

2.  Secondary:   ORR Per Blinded Independent Review Committee (BIRC) Assessment   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]

3.  Secondary:   Duration of Response (DOR) by Investigator   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]

4.  Secondary:   Duration of Response (DOR) by BIRC   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]

5.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]

6.  Secondary:   Time to Response (TTR) Per Investigator   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]

7.  Secondary:   Time to Response (TTR) Per BIRC   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]

8.  Secondary:   Progression-free Survival (PFS) Per Investigator   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]

9.  Secondary:   Progression-free Survival (PFS) Per BIRC   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]

10.  Secondary:   Overall Intracranial Response Rate (OIRR) Per Investigator   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]

11.  Secondary:   Overall Intracranial Response Rate (OIRR) Per BIRC   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]

12.  Secondary:   Overall Survival (OS)   [ Time Frame: 6 cycles of 28 days up to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01685060     History of Changes
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