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Phase 2 N=29 Treatment

Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas

Basal Cell Carcinoma (BCC) · Skin Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01108094 ↗
Enrolled (actual)
29
Serious AEs
5.3%
Results posted
Nov 2018
Primary outcome: Primary: Ki67 Tumor Proliferation Biomarker — 18; 0; -19; 13 Mean percent change — p=0.04

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Itraconazole (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Mar 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Ki67 Tumor Proliferation Biomarker		 18; 0; -19; 13 0.04 sig
SECONDARY
Change of GLI1 Tumor Biomarker		 -40.3; -16.2 0.028 sig
SECONDARY
Tumor Size		 -25.4; -20 0.435
SECONDARY
Tumor Response		 0; 0; 0; 0; 4; 0 —

Summary

Basal cell carcinomas (BCCs) are the most common human cancer in the US and affect over 1 million people. There is no effective drug to prevent basal cell carcinomas of the skin. We hope to learn if an oral anti-fungal drug, itraconazole, might inhibit a marker of proliferation and a biomarker (tumor signaling pathway) of BCC development. Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and has been used for the past 25 years with relatively few side effects. It has been shown in mice to reduce a BCC biomarker and to reduce growth of BCCs. Thus, it may reduce BCC growth in humans.

Eligibility Criteria

INCLUSION CRITERIA

  • At least one BCC tumor (greater than 4 mm in diameter) at any skin location, to be biopsied and surgically removed.
  • Had at least one liver function test [eg, aspartate aminotransferase (AST), alanine aminotransferase (ALT)] with normal results in the last year.
  • Consent to research use of their BCC tissue.
  • Cohort A or B: Willing to take itraconazole during the 2 to 3 weeks between biopsy and surgical removal of BCC

EXCLUSION CRITERIA

  • History or current hepatitis or other liver disease.
  • Currently taking systemic medications that would affect BCC tumors (oral retinoids) or metabolism of itraconazole (anti-convulsants, corticosteroids)
  • History or current evidence of malabsorption or liver disease within the one year prior to enrollment.
  • History or current evidence of hyperthyroidism increasing metabolism of itraconazole
  • Unable to attend to 2nd study visit at Stanford for Mohs surgical excision
  • Current immunosuppression disease (cancer, autoimmune disease)
  • Receiving immunosuppressive drugs
  • Pregnant
  • Lactating
  • Any female actively trying to become pregnant
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01108094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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