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An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01168349
First received: July 21, 2010
Last updated: September 1, 2015
Last verified: September 2015
Results First Received: July 23, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Anemia, Neoplasms
Intervention: Drug: epoetin beta [NeoRecormon]

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.

Participant Flow:   Overall Study
    Anemic Cancer Participants (Total Participants)
STARTED   1055 
COMPLETED   754 
NOT COMPLETED   301 
Death                157 
Lost to Follow-up                34 
Withdrawal by Subject                9 
Kidney transplantation                3 
Unspecified                22 
Protocol Violation                76 



  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.
Efficacy population included participants who had received at least 1 dose of NeoRecormon® injection and without inclusion or exclusion criteria violation.

Reporting Groups
  Description
Anemic Cancer Participants (Total Participants) Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.

Baseline Measures
   Anemic Cancer Participants (Total Participants) 
Overall Participants Analyzed 
[Units: Participants]
 979 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.4  (12.5) 
Gender 
[Units: Participants]
 
Female   528 
Male   451 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Early Treatment Response: Day 28 to 42   [ Time Frame: Day 28 to 42 ]

2.  Primary:   Percentage of Participants With Early Treatment Response: Day 21 to 42   [ Time Frame: Day 21 to 42 ]

3.  Primary:   Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion   [ Time Frame: Baseline up to Week 28 ]

4.  Primary:   Mean Number of RBC Transfusions   [ Time Frame: Baseline up to Week 28 ]

5.  Primary:   Mean Number of RBC Units   [ Time Frame: Baseline up to Week 28 ]

6.  Primary:   Time to First RBC Transfusions   [ Time Frame: Baseline up to Week 28 ]

7.  Primary:   Karnofsky Performance Status (KPS): Baseline   [ Time Frame: Baseline ]

8.  Primary:   KPS: Week 4 to 6   [ Time Frame: Week 4 to 6 ]

9.  Primary:   KPS: Week 12 to 16   [ Time Frame: Week 12 to 16 ]

10.  Primary:   KPS: Week 24 to 28   [ Time Frame: Week 24 to 28 ]

11.  Primary:   Percentage of Participants With Professional Activity: Baseline   [ Time Frame: Baseline ]

12.  Primary:   Percentage of Participants With At Least 1 Sick Leave   [ Time Frame: Week 4 Up to Week 28 ]

13.  Primary:   Mean Number of Days of Sick Leave   [ Time Frame: Week 4 Up to Week 28 ]

14.  Primary:   Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline   [ Time Frame: Baseline ]

15.  Primary:   Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6   [ Time Frame: Week 4 to 6 ]

16.  Primary:   Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16   [ Time Frame: Week 12 to 16 ]

17.  Primary:   Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28   [ Time Frame: Week 24 to 28 ]

18.  Primary:   Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6   [ Time Frame: Baseline, Week 4 to 6 ]

19.  Primary:   Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16   [ Time Frame: Baseline, Week 12 to 16 ]

20.  Primary:   Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28   [ Time Frame: Baseline, Week 24 to 28 ]

21.  Secondary:   Mean Starting Dose of NeoRecormon® Injection   [ Time Frame: Baseline ]

22.  Secondary:   Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks   [ Time Frame: Baseline ]

23.  Secondary:   Percentage of Participants With Pre-specified Dose and Frequency of Injections   [ Time Frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 ]

24.  Secondary:   Percentage of Participants With Subcutaneous (SC) Route of Administration   [ Time Frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 ]

25.  Secondary:   Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU   [ Time Frame: Baseline up to Week 28 ]

26.  Secondary:   Percentage of Participants With Modifications of NeoRecormon® Regimen   [ Time Frame: Baseline up to Week 28 ]

27.  Secondary:   Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment   [ Time Frame: Baseline up to Week 28 ]

28.  Secondary:   Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment   [ Time Frame: Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28 ]

29.  Secondary:   Relative Percent Change in Hb Concentration From Baseline Over the Study Period   [ Time Frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28 ]

30.  Secondary:   Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL   [ Time Frame: Baseline up to Week 28 ]

31.  Secondary:   Percentage of Participants With Adequate Iron Status   [ Time Frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48 ]

32.  Secondary:   Percentage of Participants With Vitamins Prescription   [ Time Frame: Week 4 to 6, Week 12 to 16, Week 24 to 48 ]


  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: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01168349     History of Changes
Other Study ID Numbers: ML22733
Study First Received: July 21, 2010
Results First Received: July 23, 2015
Last Updated: September 1, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)