Clinical Trial Results:
Vascular Targeted Photodynamic therapy with WST11 for T1a Renal Tumours. PHASE IIa histological follow up trial
Summary
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EudraCT number |
2011-003311-27 |
Trial protocol |
GB |
Global end of trial date |
11 Feb 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Feb 2019
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First version publication date |
15 Feb 2019
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Other versions |
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Summary report(s) |
VTPfinalreport |
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 |
CLIN1102KCM201
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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 |
University of Oxford
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Sponsor organisation address |
Old Road, Oxford, United Kingdom,
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Public contact |
Tom Leslie, Nuffield Department of Surgical Sciences, University of Oxford, tom.leslie@nds.ox.ac.uk
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Scientific contact |
Tom Leslie, Nuffield Department of Surgical Sciences, University of Oxford, tom.leslie@nds.ox.ac.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 |
22 Sep 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Feb 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Feb 2017
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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 evaluate efficacy of VTP treatment as assessed by histology in T1a Renal Tumours
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Protection of trial subjects |
General anaesthetic given for procedure to prevent pain and post-operative pain relief as required. Eye protection immediately post treatment to prevent eye problems in natural light.
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Background therapy |
None | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Jun 2012
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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: 5
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Worldwide total number of subjects |
5
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EEA total number of subjects |
5
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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) |
2
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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 |
- | ||||||
Pre-assignment
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Screening details |
Screening details included a history and clinical examination, performed by a trial enrolled doctor. The Trial nurse went through inclusion and exclusion criteria. Blood tests including a full blood count, urea and electrolytes and liver function tests were performed together with an electrocardiogram. CT or MRI showing a renal mass was confirmed | ||||||
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 |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Not relevant
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Arms
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Arm title
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single arm | ||||||
Arm description |
Treatment of renal tumour with WST11 | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
WST11
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion in pre-filled syringe
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
Prepared infusion. Dosage given as 2mgs/kg or 4mgs/kg as per trial protocol. Single dosage
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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 |
single arm
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Reporting group description |
Treatment of renal tumour with WST11 |
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End point title |
Extent of necrosis in renal tumour histologically [1] | ||||||||||
End point description |
The end point used was to assess tumour cell death caused by the trial treatment
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End point type |
Primary
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End point timeframe |
Necrosis was measured histologically in the surgical specimen (partial or radical nephrectomy) which was performed approximately 4 weeks following the VTP treatment
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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: Histological analysis based on microscopic assessment, n = 5 and unable to do any meaningful statistical analysis on this |
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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 |
From VTP treatment until 18 months post VTP treatment
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Adverse event reporting additional description |
Collected as per CTCAE definition. Cases assessed on day 1,2 and 12 following the VTP treatment. Further assessment was made based on individual adverse events and included 1 referral to an Opthalmologist regarding eye symptoms, follow up of a urine leak radiologically and a completion nephrectomy.
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Assessment type |
Systematic | ||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||
Dictionary version |
4.03
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Reporting groups
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Reporting group title |
APTIV
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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? Yes | |||
Date |
Amendment |
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29 Apr 2015 |
The recruitment period was extended by 12 months. The number of cases to recruit was reduced from 12 to 8 and the lower age threshold for recruitment was reduced from 60 to 50 |
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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. | |||
Early termination due to slow recruitment. leading to a smaller number than intended subjects for analysis together with the inability of MRI scanning post treatment to demonstrate the ablation zone |