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An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

This study has been terminated.
(An interim analysis was conducted in May-2014. Upon review of the data, the committee recommended study termination due to futility.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01646125
First received: June 26, 2012
Last updated: January 23, 2017
Last verified: January 2017
Results First Received: November 3, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Advanced Non Small Cell Lung Cancer (NSCLC)
Interventions: Drug: AUY922
Drug: Docetaxel
Drug: Pemetrexed

  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
Patients were randomized in a ratio of 1:1 to receive either AUY922 or pemetrexed/docetaxel. A total of 59 participants were randomized in the study: 31 to the AUY922 arm and 28 to the chemotherapy arm. 2 patients from the AUY922 arm & 5 from the chemotherapy arm were not treated. Only 52 received at least 1 dose of study medication.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AUY922 Arm

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Chemotherapy Arm

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.


Participant Flow:   Overall Study
    AUY922 Arm   Chemotherapy Arm
STARTED   31   28 
COMPLETED   0   0 
NOT COMPLETED   31   28 
Untreated                2                5 
Adverse Event                2                1 
Death                1                1 
Physician Decision                1                3 
Progressive disease                22                16 
Study terminated by sponsor                2                1 
Subject/Guardian decision                1                1 



  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) comprised of all patients who were randomized to a study treatment.

Reporting Groups
  Description
AUY922 Arm

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Chemotherapy Arm

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

Total Total of all reporting groups

Baseline Measures
   AUY922 Arm   Chemotherapy Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   28   59 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.8  (10.10)   62.1  (10.34)   61.9  (10.13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      27  87.1%      21  75.0%      48  81.4% 
Male      4  12.9%      7  25.0%      11  18.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: 16 months ]

2.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: 16 months ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: from randomization until death up to death ]

4.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: baseline, until disease progression up to 24 months ]

5.  Secondary:   Time to Response (TRR)   [ Time Frame: baseline, until disease progression up to 24 months ]

6.  Secondary:   Duration of Response (DOR)   [ Time Frame: baseline, until disease progression up to 24 months ]

7.  Secondary:   Rate of Adverse Events (AEs)   [ Time Frame: baseline, until disease progression up to 24 months ]

8.  Secondary:   Change in Laboratory Paramenters   [ Time Frame: baseline, until disease progression up to 24 months ]

9.  Secondary:   Time to Progression (TTP)   [ Time Frame: baseline, until disease progression up to 24 months ]


  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
The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results to terminate the study early due to futility, data was not collected for this assessment on many of the secondary endpoints.


  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: NCT01646125     History of Changes
Other Study ID Numbers: CAUY922A2207
2012-001050-25 ( EudraCT Number )
Study First Received: June 26, 2012
Results First Received: November 3, 2016
Last Updated: January 23, 2017