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Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01827267
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : September 11, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HER2-mutant Non-Small Cell Lung Cancer
Interventions: Drug: neratinib
Drug: temsirolimus

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Neratinib Neratinib 240 mg
Neratinib+Temsirolimus Neratinib 240 mg + Temsirolimus 15 mg.

Participant Flow:   Overall Study
    Neratinib   Neratinib+Temsirolimus
STARTED [1]   18 [2]   44 [3] 
Received Study Drug   17   43 
Crossed Over to Neratinib + Temsirolimus   11   0 
COMPLETED [4]   13   32 
NOT COMPLETED   5   12 
Did not receive study drug                1                1 
Physician Decision                1                0 
Disease Progression                1                1 
Sponsor Discontinued Study                2                8 
Still on study                0                2 
[1] Number of subjects randomized
[2] 18 subjects were randomized but 17 received treatment.
[3] 44 subjects were randomized; 43 subjects were treated.
[4] Subjects completed study upon death.



  Baseline Characteristics

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.
All subjects who received at least one dose of study medication

Reporting Groups
  Description
Neratinib Neratinib 240 mg
Neratinib+Temsirolimus Neratinib 240 mg + Temsirolimus 15 mg.
Total Total of all reporting groups

Baseline Measures
   Neratinib   Neratinib+Temsirolimus   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   43   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10  58.8%      19  44.2%      29  48.3% 
>=65 years      7  41.2%      24  55.8%      31  51.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.24  (8.88)   63.44  (12.72)   63.10  (11.70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  52.9%      32  74.4%      41  68.3% 
Male      8  47.1%      11  25.6%      19  31.7% 


  Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included. ]

2.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included. ]

3.  Secondary:   Duration of Response (DOR)   [ Time Frame: From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included. ]

4.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included. ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: From randomization to death or end of long term follow-up, assessed up to 31.8 months. ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Director, Clinical Operations
Organization: Puma Biotechnology
phone: +1 (424) 248-6500
e-mail: clinicaltrials@pumabiotechnology.com



Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01827267     History of Changes
Other Study ID Numbers: PUMA-NER-4201
2012-004743-68 ( EudraCT Number )
First Submitted: April 1, 2013
First Posted: April 9, 2013
Results First Submitted: August 8, 2017
Results First Posted: September 11, 2017
Last Update Posted: July 3, 2018