Clinical Trial Results:
An Open Label Multi-Centre Preoperative Window of Opportunity Study of Afatinib in Stage Ia to IIb Non-Small Cell Lung Cancer
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Summary
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EudraCT number |
2012-004537-16 |
Trial protocol |
GB |
Global end of trial date |
01 Aug 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Dec 2019
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First version publication date |
28 Dec 2019
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Other versions |
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Summary report(s) |
ABLE Termination Documentation |
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 |
MO11/10085
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University of Leeds
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Sponsor organisation address |
Worsley Building, Leeds, United Kingdom, LS2 9JT
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Public contact |
Dr Clive Mulatero, University of Leeds, 0113 2068650, clive.mulatero@leedsth.nhs.uk
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Scientific contact |
Dr Clive Mulatero, University of Leeds, 0113 2068650, clive.mulatero@leedsth.nhs.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 |
01 Aug 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Aug 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Aug 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 |
The principal research question is whether a reduction in the amount of energy the cancer uses can be seen when a short course of afatinib is given to early stage lung cancer patients before surgery?
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Protection of trial subjects |
To assess safety and tolerability of preoperative afatinib was a secondary objective of the trial. The Trial was overseen by a Independent Data Monitoring committee and trial steering committee, was monitored by the Sponsor twice over it's life cycle, and was conducted in accordance with GCP. Each PI retains overall responsibility for the informed consent of participants at their site and must ensure that any person delegated responsibility to participate in the informed consent process is duly authorised, trained and competent to participate according to the ethically approved protocol,principles of Good Clinical Practice (GCP) and Declaration of Helsinki 1996.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 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 |
United Kingdom: 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) |
4
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants will be recruited from NHS hospitals in the UK. The annual recruitment target is 40 participants per year.Recruitment will be competitive between participating centres. Up to 69 eligible patients may be recruited in order that a total of 59 patients will complete the protocol specified treatment. | |||||||||
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Pre-assignment
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Screening details |
Once written informed consent has been obtained and the participant has been registered, they must then be formally assessed for eligibility prior to commencing treatment.Patients identified as not eligible for trial treatment through eligibility screening will not be considered enrolled in the trial and will return to standard clinical care. | |||||||||
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Period 1
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Period 1 title |
Main Trial Period (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 | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Baseline Arm | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Afatinib
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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 |
Afatinib (BIBW2992) at a dose of 50mg orally will be administered
daily for at least two weeks prior to surgery and for a maximum of
thirty days.
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Arm title
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End Data | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Afatinib
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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 |
Afatinib (BIBW2992) at a dose of 50mg orally will be administered
daily for at least two weeks prior to surgery and for a maximum of
thirty days.
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Baseline characteristics reporting groups
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Reporting group title |
Main Trial Period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Baseline Arm
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Reporting group description |
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Reporting group title |
End Data
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Reporting group description |
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End point title |
prospectively evaluate whether changes in SUVmax can be observed with 18F-FDG PET/CT imaging after only two weeks of afatinib (BIBW2992) therapy. [1] [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
after two weeks of afatinib (BIBW2992) therapy.
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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: The trial was terminated early and no data was collected on participants. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The trial was terminated early and no data was collected on participants. |
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| Notes [3] - The trial was terminated early and no data was collected on participants. |
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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 will be collected for all participants from the time of written informed consent until 30 days post cessation of trial therapy.All AEs will be monitored until resolution, or if the AE is determined to be chronic, until a cause is identified
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | |||||||||||||||||||||||||||||||||
Dictionary version |
4.0
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Reporting groups
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Reporting group title |
Baseline Arm
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Reporting group description |
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Reporting group title |
End Data
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Reporting group description |
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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: The trial was terminated early and no data was collected on participants. |
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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? Yes | |||
Date |
Amendment |
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04 Mar 2013 |
Protocol version 4.0 dated 1st March 2013
Main PIS and consent version 4.0 dated 1st March 2013
GP letter version 4.0 dated 1st March 2013
Revised label version 4.0
Investigator Brochure version 13 dated 11 July 2012
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16 Apr 2013 |
Protocol version 5.0 dated 11 April 2013 |
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29 Nov 2013 |
Protocol version 6.2 dated 25 November 2013
Main patient information sheet and consent version 6.0 dated 25 November 2013
Patient information sheet and consent version 3.0 dated 9 May 2013
GP letter version 5.1 dated 25 November 2013
Diary card version 3.0 dated 27 September 2013
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18 Dec 2014 |
Protocol v 7.0 |
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16 Mar 2016 |
Protocol version 8.0, Amendment 6, 27 January16 March 2016
PIS version 7.0, 27 January 2016
GP Letter version 6.0, 27 January 2016
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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 | |||
