Clinical Trial Results:
Pharmacokinetics and pharmacogenetics of anticancer drugs in infants and young children
Summary
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EudraCT number |
2006-002845-36 |
Trial protocol |
GB |
Global end of trial date |
12 Sep 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Mar 2019
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First version publication date |
30 Mar 2019
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Other versions |
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Summary report(s) |
Investigating the pharmacokinetics and dosing of anticancer drugs in infants and young children. |
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 |
PK 2006 09
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00897871 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Newcastle Upon Tyne Hospitals NHS Foundation Trust
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Sponsor organisation address |
Level 1, Regent Point, Regent Farm Rd, Newcastle upon Tyne, United Kingdom, NE3 3HD
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Public contact |
Prof. Gareth Veal, Northern Institute for Cancer Research, Newcastle University, 44 01912084332, g.j.veal@newcastle.ac.uk
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Scientific contact |
Prof. Gareth Veal, Northern Institute for Cancer Research, Newcastle University, 44 01912084332, g.j.veal@newcastle.ac.uk
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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 |
08 Jun 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Sep 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Sep 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 |
The study is designed to :-
•Investigate inter-individual variability in the pharmacokinetics of selected anticancer drugs in infants and children age <2 years on current dosing schedules.
•Compare drug exposures and degree of pharmacokinetic variability in children <2 years with data obtained from published studies in older children.
• Relate inter-individual variability in pharmacokinetics and drug exposure to clinical toxicity and response.
•Use pharmacokinetic data in conjunction with clinical information obtained following treatment to investigate the suitability of current dosing regimens in infants/young children. The feasibility and clinical value of pharmacologically-guided dosing in subsequent studies in this patient population will also be considered.
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Protection of trial subjects |
Patients receiving the IMP were doing so as part of their standard clinical treatment. Blood volumes for samples taken as part of this trial were kept to a minimum and were taken from the patients central line to minimise pain and distress. Where possible PK samples were taken at the same time as clinical samples to keep discard volumes to a minimum.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Oct 2007
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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 |
United Kingdom: 63
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Worldwide total number of subjects |
63
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EEA total number of subjects |
63
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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) |
63
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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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 |
Recruitment period 22/10/07 to 08/01/13 UK wide (NHS Sites only). | ||||||
Pre-assignment
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Screening details |
Patients screened by their treating clinician/research nurses as they attended clinic for their standard care against the inclusion criteria stated in the protocol. Patients only excluded during screening if they fail to meet the study inclusion criteria. | ||||||
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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Overall Trial | ||||||
Arm description |
Overall Trial | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Carboplatin
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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 use
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Dosage and administration details |
IMP dosed according to the dosing regimen detailed in the clinical protocol on which the child is being treated.
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Investigational medicinal product name |
Cyclophosphamide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
IMP dosed according to the dosing regimen detailed in the clinical protocol on which the child is being treated.
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Investigational medicinal product name |
Etoposide
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Investigational medicinal product code |
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Other name |
Eposin
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Pharmaceutical forms |
Concentrate for concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
IMP dosed according to the dosing regimen detailed in the clinical protocol on which the child is being treated.
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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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End points reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
Overall Trial |
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End point title |
Quantification of Carboplatin, Cyclophosphamide and Etoposide plasma levels in infants [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Drug levels measured on a single course of treatment for each patient
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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: Final data analysis involved determination of pharmacokinetic parameters for this infant patient population. No formal statistical analysis was required relating to the primary endpoint. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Per patient - adverse events only to be collected for the cycle of treatment that PK sampling takes place on.
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Adverse event reporting additional description |
Only adverse events directly related to PK sampling were collected for this trial
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
NCI CTC | ||
Dictionary version |
1
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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: The study was a low risk trial simply involving the collection of blood samples following standard treatment. Adverse events were reported through the main clinical trial on which the patients were being treated. |
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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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12 Nov 2009 |
Change of sponsor from University Hospitals of Leicester NHS Trust to Newcastle upon Tyne Hospitals NHS Foundation Trust.
Change in study sponsor accompanied by change in study management to the Northern Institute for Cancer Research, Newcastle University.
Changes to protocol relate to change in study sponsor and management only (new protocol version 3.0, 1st October 2009) |
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22 Jun 2010 |
Change of Principal Investigator at St James Hospital, Leeds. No changes to protocol |
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08 Dec 2010 |
Change of Principal Investigator at Sheffield Children's Hospital. No changes to protocol |
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08 Mar 2011 |
Change of Principal Investigator at Alder Hey Children's Hospital, Liverpool. No changes to protocol |
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15 Mar 2012 |
Change of Principal Investigator at John Radcliffe Hospital, Oxford. No changes to protocol |
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15 Mar 2012 |
Change of Principal Investigator at Southampton University Hospital NHS Foundation Trust. No changes to protocol |
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19 Nov 2012 |
Change of Principal Investigator at John Radcliffe Hospital, Oxford. No changes to protocol |
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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 |