BASAL CELL CARCINOMA MedDRA version: 16.0 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: DAC-0060
Pharmaceutical Form: Gel
Trade Name: ZORAC
Product Name: ZORAC
Pharmaceutical Form: Gel
Sponsors
ISTITUTO EUROPEO DI ONCOLGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A primary histologically confirmed BCC. • Relapsing and/or not respondent BCC. • Patients aged >18 years. • Patients must have at least one unidimensionally measurable lesion between 1 and 3 cm. • Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment. • If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug. • Willing to abstain from application of non-study topical medications to the skin, during the study, including prescription and over the counter preparations. • Evidence of a personally signed and dated Ethics Committee-approved Informed Consent indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study. • Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures. • Patients already planned to undergo excision of the area treated during the trial period. • Agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package. 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: • Non melanoma skin cancer other than BCC. • Presence of active infections (e.g. requiring antibiotic therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. • Presence of known metastases. • Known to have a second uncontrolled cancer of other primary origin within the last 5 years. • Known history of hypersensitivity to any of the ingredients of the study medication formulation. • Pregnancy or breast feeding. Female patient must agree to use effective contraception, or be surgically sterile or postmenopausal. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. • Participation to other studies or treatment with an investigational study drug in the last six months. • Any conditions that in the opinion of the investigator could hamper compliance with the study protocol. • Transplanted patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess anti-tumor activity of DAC-0060 + Tazarotene 0.1% gel topic combination in the treatment of superficial and nodular basal cell skin cancer ;Secondary Objective: To evaluate the safety profile after repeated administrations of DAC-0060 + Tazarotene 0.1% gel topic combination in patients treated at the recommended doses ;Primary end point(s): Evaluation of the composite response ;Timepoint(s) of evaluation of this end point: 9 weeks after the beginning of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the objective response Evaluation of the overall response Toxicity ;Timepoint(s) of evaluation of this end point: 9 weeks after the beginning of treatment | — |
Countries
Italy
Contacts
Public ContactTRIALS & REGULATORY ACTIVITIES OFFI
ISTITUTO EUROPEO DI ONCOLGIA
Outcome results
None listed