Clinical Trial Results:
PHASE II INVESTIGATION OF CALCIUM ELECTROPORATION AS A TREATMENT FOR CUTANEOUS AND SUBCUTANEOUS MALIGNANT TUMOURS
Summary
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EudraCT number |
2019-004314-34 |
Trial protocol |
DK DE |
Global end of trial date |
04 Apr 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Nov 2024
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First version publication date |
03 Nov 2024
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Other versions |
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 |
CaEP-R
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04225767 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Zealand University Hospital
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Sponsor organisation address |
Ringstedgade 61, Næstved, Denmark,
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Public contact |
Lars Munch Larsen, Region Zealand, laml@regionsjaelland.dk
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Scientific contact |
Julie Gehl, Region Zealand, kgeh@regionsjaelland.dk
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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 |
04 Apr 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Oct 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Apr 2023
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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 |
The primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. The evaluation will use the modified RECIST criteria, clinical examination with calliper measurement and photographical documentation using adhesive rulers for scale. Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions.
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Protection of trial subjects |
Patients included had consented in writing and fulfilled all eligibility criteria. Standard safety monitoring was performed during treatment.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Feb 2020
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
12 Months | ||
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 |
Denmark: 17
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Country: Number of subjects enrolled |
Germany: 2
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Worldwide total number of subjects |
19
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EEA total number of subjects |
19
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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) |
12
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From 65 to 84 years |
6
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85 years and over |
1
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Recruitment
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Recruitment details |
Patients were recruited from three sites: Næstved (Denmark), Vejle (Denmark) and Lubeck (Germany). | ||||||
Pre-assignment
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Screening details |
Patients with any solid cancer and cutaneous metastases could be screened for inclusion. Patients could recieve other treatment, and could be included if there was no sign of regression of the cutaneous metastases - or progression. | ||||||
Period 1
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Period 1 title |
inclusion, treatment and follow-up (overall period)
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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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Experimental | ||||||
Arm description |
Patients treated with intervention (Calcium electroporation) | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Calcium chloride
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intratumoral use
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Dosage and administration details |
Tumors were measured (a longest diameter, b diameter perpendicular to a). A 3 mm margin was added.
Calcium chloride was mixed to 220 mM (mixed with sodium chloride).
a. Tumour with a diameter <0.5 cm: 1 ml of calcium chloride solution pr cm3 tumour tissue was injected.
b. Tumour with a diameter from 0.5 cm to 3 cm: 0.5 ml of calcium chloride solution pr cm3 tumour tissue was injected.
(Maximum volume is 20 ml 220 mmol/l calcium chloride.)
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Baseline characteristics reporting groups
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Reporting group title |
inclusion, treatment and follow-up
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
Patients treated with intervention (Calcium electroporation) |
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End point title |
Response at two months post treatment [1] | ||||||
End point description |
This EudraCT platform do not allow description at tumor level thus this has to be described in writing here.
At the patient level (intention to treat) 6 of 19 patients experienced response at two months.
Measuring according to tumors treated (58 tumors) the overall response rate was 36 % at the two months point.
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End point type |
Primary
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End point timeframe |
Two months post 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: In this study percent of responding lesions (descriptive statistics) were used in the primary endpoint. 58 lesions were treated in 19 patients. Please see final publication. |
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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 |
Study time period
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||
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 |
Experimental
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Reporting group description |
Patients treated with intervention (Calcium electroporation). As non-serious adverse events is not an endpoint the numbers are those who experiencen AE's at two months which are mentioned in the article: "Calcium electroporation in cutaneus metastases - A non-randomised phase II multicentre clinical trial" | ||||||||||||||||||||||||||||||||||
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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? 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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/37268521 |