Clinical Trial Results:
The influence of UGT inhibition on endoxifen exposure in cancer patients treated with tamoxifen: A proof of concept study. “The PROTAM study”
Summary
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EudraCT number |
2019-004854-27 |
Trial protocol |
NL |
Global end of trial date |
01 Jul 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
21 May 2022
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First version publication date |
21 May 2022
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Other versions |
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Summary report(s) |
Summary results |
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 |
PROTAM
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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 |
Erasmus MC
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Sponsor organisation address |
Dr Molewaterplein 40, Rotterdam, Netherlands, 3015GD
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Public contact |
R.H.J. Mathijssen, Erasmus MC Cancer Institute, a.mathijssen@erasmusmc.nl
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Scientific contact |
R.H.J. Mathijssen, Erasmus MC Cancer Institute, a.mathijssen@erasmusmc.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 |
05 May 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Jul 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jul 2021
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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 compare the Area under the curve (AUC) of endoxifen in patients with breast cancer treated with tamoxifen with and without probenecid.
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Protection of trial subjects |
Interim analysis, monitorinf and follow up by medical oncologists
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2020
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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) |
11
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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 |
Metastatic breast cancer treated with tamoxifen | ||||||
Pre-assignment
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Screening details |
- | ||||||
Pre-assignment period milestones
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Number of subjects started |
11 | ||||||
Number of subjects completed |
11 | ||||||
Period 1
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Period 1 title |
Tamoxifen (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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tamoxifen + probenecid | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
tamoxifen + probenecid
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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 |
tamoxifen: 20mg qd
Probenecid: 1000mg bid
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Baseline characteristics reporting groups
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Reporting group title |
Tamoxifen
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Endoxifen AUC0-24h
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Endoxifen AUC0-24h with and without probenecid
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End points reporting groups
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Reporting group title |
tamoxifen + probenecid
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Reporting group description |
- | ||
Subject analysis set title |
Endoxifen AUC0-24h
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Endoxifen AUC0-24h with and without probenecid
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End point title |
Endoxifen AUC0-24h [1] | ||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
0-24 hours
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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: Commented on in attachment |
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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 |
During probenecid treatment
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
5
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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: Commented on in attachment |
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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 |