Skin Basal Cell CarcinomaEarly Phase 1NCT02735356
Topical Itraconazole in Treating Patients With Basal Cell Cancer
A Early Phase 1 study testing Itraconazole in people with Skin Basal Cell Carcinoma, run by Jean Yuh Tang at 1 site in United States.
Trial summary
This phase 0 trial studies how well itraconazole gel works in treating patients with basal cell cancer. Itraconazole gel may help to treat basal cell tumors in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Basal Cell Carcinoma
- What is being tested?
- Itraconazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2016to 10 Oct 2017
- Phase
- Early Phase 1
- 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
- The subject must sign and date all informed consent statements; children will sign the assent form and their guardian will sign the consent form
- The subject must be willing to apply the medications twice daily for 1 month
- The subjects must have at least four BCCs in non-cosmetically sensitive sites
- For women of child-bearing potential, a negative urine pregnancy test
- Women of child-bearing potential are expected to use an effective method of birth control to prevent exposing a fetus to potentially dangerous agent with unknown risk
- For male patients with female partners of childbearing potential, agreement to use adequate contraception while you are participating in the study and 1 month after applying your last dose
Who cannot join
- Pregnancy or breast-feeding
- History of congestive heart failure or other findings of ventricular dysfunction
- History of current evidence of malabsorption or liver disease
- Current immunosuppression or taking immunosuppressive drugs
- Taking oral itraconazole
- Taking any medication known to affect hedgehog (HH) signaling pathway
- The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically these include the topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also - treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within 60 days to starting study medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Cancer Institute
Palo Alto, California, 94304
About this study
Official title: A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients
This phase 0 trial studies how well itraconazole gel works in treating patients with basal cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if 12 weeks of topical itraconazole gel reduces basal cell carcinoma (BCC) biomarkers (Gli1, the target gene of the Hedgehog pathway).
SECONDARY OBJECTIVES:
- To determine if topical itraconazole gel will decrease BCC size.
OUTLINE:
Patients apply itraconazole topically twice daily (BID) and placebo topically BID for 12 weeks.
After completion of study treatment, patients are followed up for up to 14 weeks.
- Conditions
- Skin Basal Cell Carcinoma
- Being tested
- Itraconazole, Placebo
- 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.
ItraconazoleDrug
Also called Lozanoc, Oriconazole, R 51,211, Sporanox
Applied topically
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Applied topically
| Study group | Role | What they receive |
|---|---|---|
| Treatment (itraconazole and placebo) | Experimental | Patients apply itraconazole topically BID and placebo topically BID for 12 weeks. Receives: Drug: Itraconazole; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of GLi levels in treated vs untreated tumors
will be assessed as relative GLi1 mRNA expression
Measured: Up to 1 month
Secondary outcomes (1)
Change in BCC tumor size
Analyzed based on tumor size change (longest diameter, Response Evaluation Criteria in Solid Tumors [RECIST] criteria).
Measured: At baseline, 1, 4, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study start5 May 2016
- Primary completion19 Sep 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Basal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean Yuh Tang
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Jean Yuh Tang, Stanford University
- Investigators
- Anthony Oro, Principal investigator, Stanford Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735356
- Sponsor's protocol ID
- IRB-35672
- Other IDs
- NCI-2016-00452, SKIN0030, P30CA124435
- Status last verified
- Apr 2019
- First submitted
- 31 Mar 2016
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients
- ClinicalTrials.gov ID
- NCT02735356
- Acronym / sponsor ID
- IRB-35672
- Conditions
- Skin Basal Cell Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Jean Yuh TangUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 May 2016 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 12 Apr 2016 (estimated)
- 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.
This phase 0 trial studies how well itraconazole gel works in treating patients with basal cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.
Detailed description
PRIMARY OBJECTIVES:
- To determine if 12 weeks of topical itraconazole gel reduces basal cell carcinoma (BCC) biomarkers (Gli1, the target gene of the Hedgehog pathway).
SECONDARY OBJECTIVES:
- To determine if topical itraconazole gel will decrease BCC size.
OUTLINE:
Patients apply itraconazole topically twice daily (BID) and placebo topically BID for 12 weeks.
After completion of study treatment, patients are followed up for up to 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (itraconazole and placebo) | Experimental | Drug: Itraconazole, Other: PlaceboPatients apply itraconazole topically BID and placebo topically BID for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject must sign and date all informed consent statements; children will sign the assent form and their guardian will sign the consent form
- The subject must be willing to apply the medications twice daily for 1 month
- The subjects must have at least four BCCs in non-cosmetically sensitive sites
- For women of child-bearing potential, a negative urine pregnancy test
- Women of child-bearing potential are expected to use an effective method of birth control to prevent exposing a fetus to potentially dangerous agent with unknown risk
Key exclusion criteria (7 listed)
- Pregnancy or breast-feeding
- History of congestive heart failure or other findings of ventricular dysfunction
- History of current evidence of malabsorption or liver disease
- Current immunosuppression or taking immunosuppressive drugs
- Taking oral itraconazole
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 |
|---|---|---|
| ItraconazoleAlso: Lozanoc, Oriconazole, R 51,211, SporanoxApplied topically | Drug | Treatment (itraconazole and placebo) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyApplied topically | Other | Treatment (itraconazole and placebo) |
Primary outcome
Percentage change of GLi levels in treated vs untreated tumors
Time frame: Up to 1 month
will be assessed as relative GLi1 mRNA expression
1 secondary outcome
Change in BCC tumor size
Time frame: At baseline, 1, 4, and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Individual participant dataSharing planned: Yes
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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.
Anthony Oro principal investigator
Stanford Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Itraconazole in people with Skin Basal Cell Carcinoma, run by Jean Yuh Tang at 1 site in United States.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 11 Apr 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change of GLi levels in treated vs untreated tumors (time frame: Up to 1 month). 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 11 Apr 2019.