PHASE II INVESTIGATION OF CALCIUM ELECTROPORATION AS ATREATMENT FOR CUTANEOUS AND SUBCUTANEOUS MALIGNANT TUMOURS
- Conditions
- Cutaneous or subcutaneous malignant tumoursMedDRA version: 21.1Level: LLTClassification code 10026693Term: Malignant skin neoplasm NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-004314-34-DE
- Lead Sponsor
- Julie Gehl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- 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