Clinical Trial Results:
Proteinuria in patients with bevacizumab (Avastin®): Identification of potential protein biomarker candidates for monitoring treatment side-effects
Summary
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EudraCT number |
2009-010857-10 |
Trial protocol |
AT |
Global end of trial date |
28 Feb 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
28 May 2017
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First version publication date |
28 May 2017
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BEV-PROT-001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
Medical University of Vienna, Medical University of Vienna, +43 1 40400 32320, andreas.peyrl@meduniwien.ac.at
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Scientific contact |
Medical University of Vienna, Medical University of Vienna, +43 1 40400 32320, andreas.peyrl@meduniwien.ac.at
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
Department of Pediatrics, Medical University of Vienna, +43 14040032320, andreas.peyrl@meduniwien.ac.at
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Scientific contact |
Department of Pediatrics, Medical University of Vienna, +43 14040032320, andreas.peyrl@meduniwien.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Feb 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Feb 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Feb 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Identification of potential biomarker proteins that (may) appear during
bevacizumab therapy
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Protection of trial subjects |
Collection of urine, no pain or stress expected
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 May 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
7
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Adolescents (12-17 years) |
8
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Pediatric patients receiving bevacizumab for therapeutic reasons | ||||||
Pre-assignment
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Screening details |
Pediatric patients receiving bevacizumab for therapeutic reasons | ||||||
Pre-assignment period milestones
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Number of subjects started |
15 | ||||||
Intermediate milestone: Number of subjects |
Receiving bevacizumab: 15
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Number of subjects completed |
15 | ||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Arm 1 | ||||||
Arm description |
Patients receiving bevacizumab | ||||||
Arm type |
Arm 1 | ||||||
Investigational medicinal product name |
Bevacizumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
10mg/kg every second week
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial (overall period)
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Reporting group description |
Overall trial | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Overall trial
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Overall trial
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End points reporting groups
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Reporting group title |
Arm 1
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Reporting group description |
Patients receiving bevacizumab | ||
Subject analysis set title |
Overall trial
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Overall trial
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End point title |
Arm 1 | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
2 weeks
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Statistical analysis title |
Mean +/- standard deviation | |||||||||
Comparison groups |
Arm 1 v Overall trial
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Number of subjects included in analysis |
30
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Mean +/- standard deviation | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Confidence interval |
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Variability estimate |
Standard deviation
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Adverse events information [1]
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Timeframe for reporting adverse events |
2 weeks
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Assessment type |
Non-systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
18.0
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Reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events occurred |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
We could not identify any potential protein biomarker candidates. |