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Topical Itraconazole in Treating Patients With Basal Cell Cancer

J

Jean Yuh Tang

Status and phase

Completed
Early Phase 1

Conditions

Skin Basal Cell Carcinoma

Treatments

Drug: Itraconazole
Other: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02735356
P30CA124435 (U.S. NIH Grant/Contract)
NCI-2016-00452 (Registry Identifier)
SKIN0030 (Other Identifier)
IRB-35672

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Treatment (itraconazole and placebo)
Experimental group
Description:
Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.
Treatment:
Other: Placebo
Drug: Itraconazole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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