Clinical Trial Results:
Lean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)
Summary
|
|
EudraCT number |
2011-005168-14 |
Trial protocol |
NL |
Global end of trial date |
01 Aug 2016
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
21 Sep 2019
|
First version publication date |
21 Sep 2019
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
UMCN-AKF11.01
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Radboudumc
|
||
Sponsor organisation address |
Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
|
||
Public contact |
Angela Colbers, Radboud University Nijmegen Medical Centre, angela.colbers@radboudumc.nl
|
||
Scientific contact |
Angela Colbers, Radboud University Nijmegen Medical Centre, angela.colbers@radboudumc.nl
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
01 Aug 2016
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
20 Aug 2015
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
01 Aug 2016
|
||
Was the trial ended prematurely? |
Yes
|
||
General information about the trial
|
|||
Main objective of the trial |
To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females.
|
||
Protection of trial subjects |
Subjects experience only limited burden or risk during study related assessments of one DEXA scan, one BIA measurement and withdrawal of 4 pharmacokinetic blood samples. Subjects will not have direct benefit of participating in the study.
Subjects may experience side effects of the medication administered for the treatment of cancer. The choice for treatment will be made by their treating physician, this will not be influenced by this study.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2012
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Netherlands: 32
|
||
Worldwide total number of subjects |
32
|
||
EEA total number of subjects |
32
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
26
|
||
From 65 to 84 years |
6
|
||
85 years and over |
0
|
|
|||||||||||
Recruitment
|
|||||||||||
Recruitment details |
32 patients included in 2 centres in the Netherlands | ||||||||||
Pre-assignment
|
|||||||||||
Screening details |
Subjects who are diagnosed with breast or metastatic castration-resistant prostate carcinoma who will receive docetaxel containing treatment according to standard hospital protocol | ||||||||||
Period 1
|
|||||||||||
Period 1 title |
screening
|
||||||||||
Is this the baseline period? |
No | ||||||||||
Allocation method |
Not applicable
|
||||||||||
Blinding used |
Not blinded | ||||||||||
Arms
|
|||||||||||
Arm title
|
docetaxel | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Active comparator | ||||||||||
Investigational medicinal product name |
docetaxel
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Infusion
|
||||||||||
Routes of administration |
Intravenous use
|
||||||||||
Dosage and administration details |
20mg/mL
|
||||||||||
|
|||||||||||
Period 2
|
|||||||||||
Period 2 title |
PK day
|
||||||||||
Is this the baseline period? |
Yes [1] | ||||||||||
Allocation method |
Not applicable
|
||||||||||
Blinding used |
Not blinded | ||||||||||
Arms
|
|||||||||||
Arm title
|
docetaxel | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
docetaxel
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Infusion
|
||||||||||
Routes of administration |
Intravenous use
|
||||||||||
Dosage and administration details |
20mg/mL
|
||||||||||
Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: baseline was performed on PK day, not at screening. |
|||||||||||
|
|||||||||||
Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: we do not have these data in the database from the patients screened but not included. |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
PK day
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
docetaxel
|
||
Reporting group description |
- | ||
Reporting group title |
docetaxel
|
||
Reporting group description |
- |
|
|||||||||
End point title |
correlation with BSA [1] | ||||||||
End point description |
correlation dosing on BSA and docetaxel clearance
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
entire study
|
||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: correlation between AUC and TBW was done, it is not possible to put that analysis in the statics fields. Pearson correlation coefficients were reported, p value all >0.05 |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Correlation LBM [2] | ||||||||
End point description |
correlation dosing on LBM and docetaxel clearance
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
entire study
|
||||||||
Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: correlation between AUC and BSA was done, it is not possible to put that analysis in the statics fields. Pearson correlation coefficients were reported, p value all >0.05 |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
correlation TBW [3] | ||||||||
End point description |
correlation dosing on TBW and docetaxel clearance
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
entire study
|
||||||||
Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: correlation between AUC and LBM was done, it is not possible to put that analysis in the statics fields. Pearson correlation coefficients were reported, p value all >0.05 |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||
Adverse events information [1]
|
|||||||||||
Timeframe for reporting adverse events |
entire study
|
||||||||||
Assessment type |
Non-systematic | ||||||||||
Dictionary used for adverse event reporting
|
|||||||||||
Dictionary name |
none | ||||||||||
Dictionary version |
1
|
||||||||||
Reporting groups
|
|||||||||||
Reporting group title |
LEANDOC
|
||||||||||
Reporting group description |
- | ||||||||||
|
|||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
|
|||||||||||
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 were reported. |
|
|||||||
Substantial protocol amendments (globally) |
|||||||
Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
||||||
20 Dec 2013 |
In the synopsis the requirement of 20 female breast carcinoma patients and 20 castration resistant prostate carcinoma patients has been changed. We will include 40 subjects either patients with breast carcinoma or castration resistant prostate carcinoma which receive docetaxel as part of their treatment. |
||||||
Interruptions (globally) |
|||||||
Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |