Clinical Trial Results:
Cerebrospinal fluid (CSF) and plasma pharmocokinetics of liposomal cytarabine (DepoCyte®) after intrathecal administration in children with malignant brain tumors and leptomeningeal dissemination
Summary
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EudraCT number |
2006-004982-32 |
Trial protocol |
AT |
Global end of trial date |
23 Oct 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Feb 2016
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First version publication date |
28 Feb 2016
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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 |
LIPDEP-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 14040032320, andreas.peyrl@meduniwien.ac.at
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Scientific contact |
Medical University of Vienna, 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 |
23 Oct 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Oct 2013
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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 |
CSF: AUC, t1/2, Cmax, Cmin, Cav(ss)
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Protection of trial subjects |
Using an Ommaya reservoir for CSF sampling
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Dec 2006
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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: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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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) |
2
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Children (2-11 years) |
11
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Adolescents (12-17 years) |
6
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Adults (18-64 years) |
1
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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 with a malignant CNS tumor and leptomeningeal dissemination or risk of leptomeningeal dissemination | ||||||
Pre-assignment
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Screening details |
Pediatric patients with a malignant CNS tumor and leptomeningeal dissemination or risk of leptomeningeal dissemination | ||||||
Pre-assignment period milestones
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Number of subjects started |
20 | ||||||
Number of subjects completed |
20 | ||||||
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 |
- | ||||||
Arm type |
Arm 1 | ||||||
Investigational medicinal product name |
Liposomal cytarabine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intraventricular use
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Dosage and administration details |
25-50mg intraventricular
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||
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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 |
- | ||
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 |
CSF concentration of liposomal cytarabine | |||||||||||||||
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 |
40
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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
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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: 1% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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11 Feb 2010 |
In the different age groups with different dosing, the number of patients that have been recruited varied.
To get reasonable pharmacokinetics values in the different age groups, recruitment of additional patients was necessary.
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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. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/19492871 http://www.ncbi.nlm.nih.gov/pubmed/24129691 |