PHASE II INVESTIGATION OF CALCIUM ELECTROPORATION AS A TREATMENT FOR CUTANEOUS AND SUBCUTANEOUS MALIGNANT TUMOURS
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]Cutaneous or subcutaneous malignant tumoursMedDRA version: 21.1 Level: LLT Classification code 10026693 Term: Malignant skin neoplasm NOS System Organ Class: 100000004864
- Registration Number
- EUCTR2019-004314-34-DK
- Lead Sponsor
- Julie Gehl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 30
•Trial subject = 18 years.
•Trial subject must be able to understand the participant information.
•Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
•The patient must have been offered other relevant standard treatment for their cancer disease.
•The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.) if progressive or stable disease is present after a treatment period of two months or more.
•The patient can undergo radiation therapy, provided that the treatment field does not involve treated area.
•Performance status ECOG/WHO =2.
•At least one cutaneous or subcutaneous tumour measuring up to 3 cm.
•Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch).
•Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
•Pregnancy or lactation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method