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LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01828112
First received: April 2, 2013
Last updated: June 27, 2017
Last verified: June 2017
Results First Received: June 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: Ceritinib
Drug: pemetrexed
Drug: docetaxel

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
115 patients received ceritinib and 116 received chemotherapy among which 40 patients received pemetrexed, 73 patients received docetaxel, and 3 were not treated (2 patients due to Investigators decision and 1 due to subject/guardian’s decision).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 231 patients were randomized in a 1:1 ratio to the ceritinib arm (n=115) or the chemotherapy arm (n=116).

Reporting Groups
  Description
Ceritinib Ceritinib 750 mg
Chemotherapy Chemotherapy as determined by BIRC.

Participant Flow:   Overall Study
    Ceritinib   Chemotherapy
STARTED   115   116 
Entered Extension Treatment Phase   0   74 
Entered Post-treatment Follow-up Phase   7   5 
Entered Survival Follow-up Phase   61   19 
Discontinued From Study   14   10 
Untreated Patients   0   3 [1] 
Untreated   0   3 
Treated   115   113 
COMPLETED   33 [2]   8 [2] 
NOT COMPLETED   82   108 
Adverse Event                6                8 
Death                9                5 
Physician Decision                5                5 
Progressive disease                56                82 
Subject/guardian decision                6                8 
[1] untreated = did not receive study drug
[2] Completed = Ongoing at time of data cut-off of 26-Jan-2016



  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.
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.

Reporting Groups
  Description
Ceritinib Ceritinib 750 mg
Chemotherapy Chemotherapy as determined by BIRC.
Total Total of all reporting groups

Baseline Measures
   Ceritinib   Chemotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 115   116   231 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.1  (11.96)   54.4  (11.61)   53.7  (11.78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      68  59.1%      61  52.6%      129  55.8% 
Male      47  40.9%      55  47.4%      102  44.2% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   30   38   68 
Black   0   1   1 
Caucasian   81   68   149 
Other   2   4   6 
Unknown   2   5   7 


  Outcome Measures

1.  Primary:   Progression Free Survival (PFS) Blinded Independent Review Committee Per Blinded Independent Review Committee (BIRC)   [ Time Frame: After approximately 161 PFS events had been documented by BIRC ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Month 18 ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  

3.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Month 18 ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  

4.  Secondary:   Duration of Response (DOR)   [ Time Frame: Month 18 ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  

5.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: Month 18 ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  

6.  Secondary:   Time to Response (TTR)   [ Time Frame: Month 18 ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  

7.  Secondary:   Patient Reported Outcomes (PRO)   [ Time Frame: Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  

8.  Secondary:   Time to Definitive Deterioration   [ Time Frame: from the date of randomization to the date of event for disease related symptoms ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  

9.  Secondary:   Overall Intracranial Response Rate (OIRR)   [ Time Frame: Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  

10.  Secondary:   Intracranial Disease Control Rate (IDCR)   [ Time Frame: Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  

11.  Secondary:   Duration of Intracranial Response (DOIR)   [ Time Frame: Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
Although 116 patients were randomized to the Chemotherapy arm, 3 did not receive study drug and were excluded form the Safety set.


  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: NCT01828112     History of Changes
Other Study ID Numbers: CLDK378A2303
2012-005637-36 ( EudraCT Number )
Study First Received: April 2, 2013
Results First Received: June 24, 2017
Last Updated: June 27, 2017