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Trial record 52 of 580 for:    Advanced | cancer | bevacizumab

Safety and Efficacy Study of Avastin in Locally Advanced Metastatic or Recurrent Non-small Lung Cancer (NSLC) Participants

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ClinicalTrials.gov Identifier: NCT02596958
Recruitment Status : Completed
First Posted : November 4, 2015
Results First Posted : March 4, 2016
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Cross-Sectional
Condition: Non-Squamous Non-Small Cell Lung Cancer
Intervention: Drug: Bevacizumab

  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
Bevacizumab Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current summary of product characteristics (SmPC).

Participant Flow:   Overall Study
    Bevacizumab
STARTED   996 
COMPLETED   0 
NOT COMPLETED   996 
Serious Adverse Drug Reactions                44 
Cancer Progression                441 
Death From Cancer                112 
Death From Other Cause                33 
Refusal of Treatment/Poor Cooperation                61 
Administrative Reasons/Other                231 
Lost to Follow-up                33 
Missing                32 
Excluded Due to Second Line Treatment                9 



  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.
Analysis population was defined as all participants included in the observational study, regardless of whether they finished it or not. Nine hundred and ninety six (996) participants were documented but only 987 participants were included in the analysis population as 9 participants were excluded due to documented second line treatment.

Reporting Groups
  Description
Bevacizumab Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.

Baseline Measures
   Bevacizumab 
Overall Participants Analyzed 
[Units: Participants]
 987 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.5  (9.8) 
Gender, Customized 
[Units: Participants]
 
Female   396 
Male   590 
Missing   1 


  Outcome Measures

1.  Primary:   Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs   [ Time Frame: Up to 74 months ]

2.  Secondary:   Percentage of Participants Who Withdrew or Modified Treatment   [ Time Frame: Up to 74 months ]

3.  Secondary:   Number of Cycles of Systemic Therapy   [ Time Frame: Up to 74 months ]

4.  Secondary:   Percentage of Participants With Best Tumor Response Over Time   [ Time Frame: Up to 74 months ]

5.  Secondary:   Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades   [ Time Frame: Up to 74 months ]

6.  Secondary:   Percentage of Participants With Disease Control   [ Time Frame: Up to 74 months ]

7.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Up to 74 months ]

8.  Secondary:   Percentage of Participants Who Died   [ Time Frame: Up to 74 months ]

9.  Secondary:   Overall Survival   [ Time Frame: Up to 74 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 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: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02596958     History of Changes
Other Study ID Numbers: ML21217
First Submitted: November 3, 2015
First Posted: November 4, 2015
Results First Submitted: February 5, 2016
Results First Posted: March 4, 2016
Last Update Posted: April 4, 2016