Basal Cell CarcinomaNCT03972748
Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.
A study testing Itraconazole 200 mg in people with Basal Cell Carcinoma and Hedgehog Pathway, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Hedgehog Pathway
- What is being tested?
- Itraconazole 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jan 2018to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
Renato M Bakos, Ph.D., +555133598000 ext. 8619, rbakos@hcpa.edu.br
About this study
Official title: Evaluation Of The Treatment With Oral Itraconazole In Patients With Basocellular Carcinoma Of Skin, Locally Limited Disease.
Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg twice daily, for 60 days, prior to curative intent surgery.
Read the detailed description
Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg once daily, for 60 days, before surgery with curative intent.
Tumor area regression will be measured through dermatologic evaluation and photographic documentation on baseline and at the end of the 60 day treatment period.
The activity of the Hedgehog pathway will be measured on tissue samples obtained at the time of diagnosis and at the time of curative intent surgery, through the measuring of the Ki67 index.
- Conditions
- Basal Cell Carcinoma, Hedgehog Pathway
- Being tested
- Itraconazole 200 mg
- Keywords
- Itraconazole
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itraconazole 200 mgDrug
Oral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent.
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole | Experimental | Oral Itraconazole capsules, 200 mg Receives: Drug: Itraconazole 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response
tumor area response registered through dermatologic evaluation
Measured: 60 days
hedgehog pathway activity
Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start5 Jan 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato M Bakos, Ph. D., Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972748
- Sponsor's protocol ID
- 47011715.0.0000.5327
- Status last verified
- May 2019
- First submitted
- 31 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Treatment With Oral Itraconazole In Patients With Basocellular Carcinoma Of Skin, Locally Limited Disease.
- ClinicalTrials.gov ID
- NCT03972748
- Acronym / sponsor ID
- 47011715.0.0000.5327
- Conditions
- Basal Cell Carcinoma, Hedgehog Pathway
- Keywords
- Itraconazole
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg twice daily, for 60 days, prior to curative intent surgery.
Detailed description
Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg once daily, for 60 days, before surgery with curative intent.
Tumor area regression will be measured through dermatologic evaluation and photographic documentation on baseline and at the end of the 60 day treatment period.
The activity of the Hedgehog pathway will be measured on tissue samples obtained at the time of diagnosis and at the time of curative intent surgery, through the measuring of the Ki67 index.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Itraconazole | Experimental | Drug: Itraconazole 200 mgOral Itraconazole capsules, 200 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itraconazole 200 mgOral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent. | Drug | Itraconazole |
Primary outcome
clinical response
Time frame: 60 days
tumor area response registered through dermatologic evaluation
hedgehog pathway activity
Time frame: 60 days
Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renato M Bakos, Ph. D. study chair
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Itraconazole 200 mg in people with Basal Cell Carcinoma and Hedgehog Pathway, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renato M Bakos, Ph. D. (+555133598000 ext. 8619, rbakos@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical response (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.