Clinical trial • Phase II/III • Oncology | Dermatology

BLEOMYCIN for Basal cell carcinoma

Phase II/III trial of BLEOMYCIN for Basal cell carcinoma.

Overview

Trial Therapeutic Area
Oncology | Dermatology
Trial Disease
Basal cell carcinoma
Trial Stage
Phase II/III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
03-12-2024
First CTIS Authorization Date
16-12-2024

Trial design

Randomised, standard radiotherapy (comparator) — dose/schedule not specified; electrochemotherapy with intratumoral bleomycin (investigational arm) — details of bleomycin dosing/schedule not specified-controlled Phase II/III trial across 1 site in Denmark.

Randomised
Yes
Comparator
Standard radiotherapy (comparator) — dose/schedule not specified; Electrochemotherapy with intratumoral Bleomycin (investigational arm) — details of bleomycin dosing/schedule not specified
Target Sample Size
52

Eligibility

Recruits 52 Vulnerable population selected. Informed consent required: 'Subject must understand patient information' and 'Signed informed consent'. Consent is provided by the participant; no mention of assent or proxy consent in the available documentation..

Pregnancy Exclusion
Pregnancy or breast feeding
Vulnerable Population
Vulnerable population selected. Informed consent required: 'Subject must understand patient information' and 'Signed informed consent'. Consent is provided by the participant; no mention of assent or proxy consent in the available documentation.

Inclusion criteria

  • {"criterion_text":"- Age above 18 years\n- Biopsy verified basal cell carcinoma under 3 cm accessible for both radiotherapy and elechtrochemoterapy\n- Subject must understand patient information\n- Signed informed consent"}

Exclusion criteria

  • {"criterion_text":"- Metastatic basal cell carcinoma\n- Previous treatment with bleomycin above 200.000 Units/m2\n- Previous severe allergic reactions to bleomycin\n- Pregnancy or breast feeding\n- Participation in other trials with trial medication"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Effect of electhrochemotherapy versus standard radiotherapy for the treatment of basal cell carcinomas less than 3 cm.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Adverse events\n- Cosmesis\n- Patient satisfaction","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
52
Recruitment Window Months
92
Consent Approach
Informed consent: 'Signed informed consent' required from participant; participant must understand patient information. Subject information and consent forms are indicated (L1_SIS_DK, L1_ICF_DK) — available in Danish. No mention of assent, proxy consent, or other languages in the available documentation.

Geography

Total Number Of Sites
1
Total Number Of Participants
52

Denmark

Earliest CTIS Part Ii Submission Date
10-12-2024
Latest Decision Or Authorization Date
16-12-2024
Processing Time Days
6
Number Of Sites
1
Number Of Participants
52

Sites

Site Name
Region Hovedstaden, Borgmester Ib Juuls Vej 1
Department Name
Dept. of Oncology
Contact Person Name
Camilla Kjaer Loenkvist

Sponsor

Primary sponsor

Full Name
Region Hovedstaden
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Bleomycin ”Baxter”, pulver til injektions- og infusionsvæske, opløsning
Active Substance
BLEOMYCIN
Modality
Small molecule
Routes Of Administration
Intratumoral
Route
Intratumoral
Authorisation Status
Marketing authorisation in Denmark (MarketingAuthorisationNumber: 05689)
Maximum Dose
9000 IU

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