Clinical Trial Results:
Increasing pazopanib exposure by splitting intake moments
Summary
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EudraCT number |
2016-005252-21 |
Trial protocol |
NL |
Global end of trial date |
12 Mar 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Feb 2021
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First version publication date |
22 Feb 2021
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Other versions |
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Summary report(s) |
Groenland et al (Clin Pharmacokinet, 2020) - pazopanib split intake |
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 |
N17PSI
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
CCMO dossier number: NL60393.031.17, NL trialregister: NL6137 | ||
Sponsors
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Sponsor organisation name |
Netherlands Cancer Institute
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Sponsor organisation address |
Plesmanlaan 121, Amsterdam, Netherlands, 1066CX
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Public contact |
Steffie Groenland, Netherlands Cancer Institute, s.groenland@nki.nl
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Scientific contact |
Steffie Groenland, Netherlands Cancer Institute, s.groenland@nki.nl
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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 |
20 Dec 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Jan 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Mar 2019
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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 show whether switching patients from a once daily (QD) to a twice daily (BID) dosing schedule will lead to a significant increase in pharmacokinetic exposure, measured as Cmin and AUC0-24h.
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Protection of trial subjects |
Theoretically, a possible risk of additional toxicity exists, as we expect an increase in exposure by splitting intake moments of pazopanib. However, this risk is minimized by:
- The short duration of the intervention (only seven days);
- The exclusion of patients with a high Cmin at screenin
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2017
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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 |
Netherlands: 11
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Worldwide total number of subjects |
11
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EEA total number of subjects |
11
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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) |
7
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||
Pre-assignment
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Screening details |
Patients with histological or cytological proof of cancerwith an indication for treatment with pazopanib (i.e., advanced RCC or STS) were eligible for inclusion. Since evidence suggests pazopanib exposure may drop during the first weeks of treatment, all patients needed to be on pazopanib 800 mg QD treatment ≥ 3 weeks prior to start of the study. | ||||||||||
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 |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Arm1 | ||||||||||
Arm description |
- | ||||||||||
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 |
Cross-over pazopanib 800 mg QD or pazopanib 400 mg twice daily
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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 |
Arm1
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Reporting group description |
- |
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End point title |
The primary endpoint of this study was to evaluate whether switching patients from an 800 mg QD to a 400 mg BID dosing schedule would lead to an increase in pharmacokinetic exposure, measured as Cmin and area under the concentration– time curve from zero [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Time points at day 1 (800 mg QD) were pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 24 h post-dose. Time points at day 8 (400 mg BID) were predose
and 1, 2, 3, 4, 5, 6, 8, 10, 12, 13, 14, 15, 16, and 24 h post-dose.
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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: See table 2 of publication attached |
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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 |
Adverse events should be collected beginning from day 1 of the study and ending with the end of the study.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
CTC | ||
Dictionary version |
4.03
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Frequency threshold for reporting non-serious adverse events: 1% | |||
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: See table 3 of publication attached. |
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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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19 Jun 2017 |
Erasmus Medical Center added as trial center.
Change in data collection (eCRF)
Clarification in SAE reporting procedures. |
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03 Jul 2018 |
-New independent physician
-New privacy legislation |
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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 |