Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.
Evaluation Of The Treatment With Oral Itraconazole In Patients With Basocellular Carcinoma Of Skin, Locally Limited Disease.
1 other identifier
interventional
28
1 country
1
Brief Summary
Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg twice daily, for 60 days, prior to curative intent surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2018
CompletedFirst Submitted
Initial submission to the registry
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJune 4, 2019
May 1, 2019
2.9 years
May 31, 2019
May 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
clinical response
tumor area response registered through dermatologic evaluation
60 days
hedgehog pathway activity
Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.
60 days
Study Arms (1)
Itraconazole
EXPERIMENTALOral Itraconazole capsules, 200 mg
Interventions
Oral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent.
Eligibility Criteria
You may qualify if:
- Patients with diagnosis of Basocellular Carcinoma (BCC) of the Skin, histologically confirmed.
- At least one BCC lesion with 10 mm in the longest diameter
- Disease amenable to surgical intervention with curable intent.
- Signed Informed Consent
- PS ECOG 0 to 3
You may not qualify if:
- Chronic renal disease, with a glomerular filtration rate of less than 30 ml/min
- Acute or chronic liver disease, as measured by: total bilirubin \> than 1.5 x ULN and AST and ALT \> than 5 x ULN.
- Symptomatic cardiac insufficiency or an ejection fraction lower than 50% measured through echocardiography,
- Other active malignancies in the last year.
- Uncontrolled systemic hypertension,
- Any chronic infections such as tuberculosis, viral hepatitis and HIV.
- Pregnancy, suspected or confirmed.
- Known intolerance to the use of Itraconazole.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Renato M Bakos, Ph. D.
Hospital de Clinicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2019
First Posted
June 4, 2019
Study Start
January 5, 2018
Primary Completion
December 1, 2020
Study Completion
June 1, 2021
Last Updated
June 4, 2019
Record last verified: 2019-05