Clinical Trial Results:
Influence of an Acidic Beverage (Coca-Cola) on the exposure to Imatinib (GLIvec) after major gastrecTomY in patients with Gastrointestinal Stromal Tumors (ABILITY)
Summary
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EudraCT number |
2014-001044-38 |
Trial protocol |
NL |
Global end of trial date |
03 Nov 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Oct 2019
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First version publication date |
24 Oct 2019
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Other versions |
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Summary report(s) |
ABILITY PAPER |
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-AKF14.01
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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 |
Radboudumc
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Sponsor organisation address |
Geert Grooteplein zuid 10, Nijmegen, Netherlands,
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Public contact |
David Burger, Radboud University Nijmegen Medical Center, david.burger@radboudumc.nl
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Scientific contact |
David Burger, Radboud University Nijmegen Medical Center, david.burger@radboudumc.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 |
12 Jan 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Nov 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Nov 2016
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To assess the effects of Coca-Cola on the exposure to imatinib in patients with major gastrectomy.
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Protection of trial subjects |
The drug is licensed on the Dutch market for the dose administered. The only intervention is adding Coca-Cola to the dosing regimen, possibly increasing exposure to imatinib. There is no attributable risk for the application of the study protocol to the patients.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2014
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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: 7
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Worldwide total number of subjects |
7
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EEA total number of subjects |
7
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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 |
0
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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 histologically confirmed GIST, who have undergone major gastrectomy and are currently treated or will start imatinib therapy were elibible | |||||||||
Period 1
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Period 1 title |
screening
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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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screening | |||||||||
Arm description |
- | |||||||||
Arm type |
screening | |||||||||
Investigational medicinal product name |
imatinib
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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 |
none
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Period 2
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Period 2 title |
treatment
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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imatinib alone | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
imatinib
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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 |
400-800mg daily
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Arm title
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imatinib + coca cola | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
imatinib
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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 |
400-800mg + coca cola
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Baseline characteristics reporting groups
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Reporting group title |
screening
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
screening
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Reporting group description |
- | ||
Reporting group title |
imatinib alone
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Reporting group description |
- | ||
Reporting group title |
imatinib + coca cola
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Reporting group description |
- |
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End point title |
AUC imatinib | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
whole trial
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Statistical analysis title |
geometric mean ratio | ||||||||||||
Comparison groups |
imatinib + coca cola v imatinib alone
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Number of subjects included in analysis |
14
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Analysis specification |
Pre-specified
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Analysis type |
[1] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
geometric mean ratio | ||||||||||||
Point estimate |
1.04
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
0.94 | ||||||||||||
upper limit |
1.14 | ||||||||||||
Notes [1] - intrasubject comparison, 7 subjects in total, not 14 |
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Adverse events information [1]
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Timeframe for reporting adverse events |
entire study
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Assessment type |
Non-systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
none | ||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
imatinib
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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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 |
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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? Yes | |||||||
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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/28677263 |