Clinical trial · Interventional
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.
NCT03972748CI-TRIAL-00038919unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg twice daily, for 60 days, prior to curative intent surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Hedgehog Pathway | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Itraconazole 200 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Itraconazole
- description
- Oral Itraconazole capsules, 200 mg
- interventionNames
- Drug: Itraconazole 200 mg
Primary outcomes (2)
- measure
- clinical response
- timeFrame
- 60 days
- description
- tumor area response registered through dermatologic evaluation
- measure
- hedgehog pathway activity
- timeFrame
- 60 days
- description
- Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.