Safety and Effect of Pertuzumab in Patients With Advanced Non-Small Cell Lung Cancer, Which Has Progressed After Prior Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00063154
First received: June 20, 2003
Last updated: June 8, 2015
Last verified: June 2015
Results First Received: May 26, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Intervention: Drug: Pertuzumab

  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
No text entered.

Reporting Groups
  Description
Pertuzumab Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.

Participant Flow:   Overall Study
    Pertuzumab  
STARTED     51  
COMPLETED     0  
NOT COMPLETED     51  
Disease progression                 27  
Adverse Event                 2  
Physician Decision                 10  
Death                 3  
Reason unspecified                 1  
Did not receive treatment                 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.
Safety population: All participants who received any amount of pertuzumab.

Reporting Groups
  Description
Pertuzumab Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.

Baseline Measures
    Pertuzumab  
Number of Participants  
[units: participants]
  43  
Age  
[units: years]
Mean (Standard Deviation)
  62.5  (9.1)  
Gender  
[units: participants]
 
Female     17  
Male     26  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)   [ Time Frame: Baseline to the end of the study (up to 1 year) ]

2.  Secondary:   Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors   [ Time Frame: Baseline to the end of the study (up to 1 year) ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Baseline to the end of the study (up to 1 year) ]

4.  Secondary:   Number of Participants Free From Disease Progression at 3, 6, and 12 Months   [ Time Frame: Baseline to the end of the study (up to 1 year) ]


  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: Medical Communications
Organization: Genentech, Inc.
phone: 800 821-8590
e-mail: genentech@druginfo.com



Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00063154     History of Changes
Obsolete Identifiers: NCT00095602
Other Study ID Numbers: TOC2572g
Study First Received: June 20, 2003
Results First Received: May 26, 2015
Last Updated: June 8, 2015
Health Authority: United States: Food and Drug Administration