Clinical Trial Results:
Individualizing Pazopanib therapy by exploRing the role of Early metabolic responsE and drug exposure as a preDICTor for treatment outcome in patients with STS
Summary
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EudraCT number |
2013-003533-16 |
Trial protocol |
NL |
Global end of trial date |
24 Nov 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Jun 2021
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First version publication date |
12 Jun 2021
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Other versions |
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Summary report(s) |
Medical Journal Article |
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 |
UMCN-ONCO-201303
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01995981 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Radboud University Nijmegen Medical Centre
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Sponsor organisation address |
Geert Grooteplein 10, Nijmegen, Netherlands,
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Public contact |
Research verpleegkundigen oncologie, Radboud University Nijmegen Medical Centre, 0031 243610353,
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Scientific contact |
Research verpleegkundigen oncologie, Radboud University Nijmegen Medical Centre, 0031 243610353,
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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 |
03 Dec 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 May 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Nov 2017
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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 |
To evaluate whether early metabolic response is correlated to clinical benefit. And to evaluate the effect of age on pazopanib pharmacokinetcs.
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Protection of trial subjects |
The study included additional PETscans and PK analysis for which only one IV line was used.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Oct 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Netherlands: 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) |
0
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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) |
12
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment in the Radboud University Medical Center in Nijmegen and the Antoni van Leeuwenhoek – Netherlands Cancer Institute in Amsterdam | ||||||
Pre-assignment
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Screening details |
Inclusion and exclusion criteria were similar to those used in the PALETTE trial: van der Graaf WT, et al. Pazopanib for metastatic soft tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 379: 1879-1886, 2012. PMID: 22595799. | ||||||
Period 1
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Period 1 title |
Inclusion (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
N/A
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Arms
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Arm title
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FDG-PET | ||||||
Arm description |
The study was designed as a prospective observational feasibility study | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Pazopanib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
800 mg pazopanib once daily
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Baseline characteristics reporting groups
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Reporting group title |
Inclusion
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
FDG-PET
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Reporting group description |
The study was designed as a prospective observational feasibility study | ||
Subject analysis set title |
PK AUC0-24h
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
AUC 0-24h
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Subject analysis set title |
PK Ctrough
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Ctrough levels
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End point title |
FDG-PET/CT can be used for early monitoring of response to pazopanib treatment in STS patients [1] | |||
End point description |
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End point type |
Primary
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End point timeframe |
10-10-2013 - 26-5-2017
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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: No statistical analyses were performed as this was a pilot observational study. Only descriptives were given. |
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No statistical analyses for this end point |
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End point title |
there is an association between FDG-PET/CT response and pazopanib concentration/exposure [2] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
oct 2013- may 2017
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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: No statistical analyses were performed as this was a pilot observational study. Only descriptives were given. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
oct 2013 - may 2017
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCTAE | ||||||||||||||||||||||||||||||||
Dictionary version |
4.0
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Reporting groups
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Reporting group title |
Patiënts
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Reporting group description |
- | ||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||
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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. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/30842163 |