PHASE II INVESTIGATION OF THE HISTOPATHOLOGIC EFFECT OF CALCIUM ELECTROPORATION ON CANCER IN THE SKI

Phase 1

• Conditions: Cutaneous metastases from solid cancer of any histology; MedDRA version: 21.1Level: LLTClassification code 10026693Term: Malignant skin neoplasm NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004315-31-DK
• Lead Sponsor: Julie Gehl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-08
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

•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 can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.).
•The patient can undergo radiation therapy during the study period, provided that the treatment field does not involve the treated area.
•Performance status ECOG/WHO =2
•At least one cutaneous or subcutaneous tumour measuring at least 5 mm.
•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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

Exclusion criteria

•Pregnancy or lactation
•Allergy to local anaesthesia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified