Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Ce… (NCT01556009) | Clinical Trial Compass
CompletedPhase 2
Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas
United States24 participantsStarted 2012-04
Plain-language summary
The purpose of this study is to evaluate and compare the safety and efficacy of intermittent vismodegib and of Photodynamic Therapy (PDT).
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
The subject:
* has had diagnosed at least 10 SEB (of diameter 3 mm diameter or greater on the nose or periorbital skin, 5 mm or greater elsewhere on the face, or 9 mm or greater on non-facial areas excluding the skin below the knees) during the two years before study entry.
* meet diagnostic criteria for basal cell nevus syndrome
* is willing to abstain from application of non-study topical medications to the skin for the duration of the study. For example, topical preparations containing corticosteroids (other than Triamcinolone applied no more than 6x/month).
* is willing to forego treatment of BCCs unless the BCCs are documented by Study Investigators, preferably on two separate visits, except when the PSCP believes that delay in treatment potentially might compromise the health of the subject.
* has normal laboratory tests as defined by the following: Normal hematopoietic capacity, Normal hepatic function: AST and ALT greater than or equal to 2x the upper limit of normal (ULN) Total bilirubin within normal range 0.20 mg/dl to 1.50 mg/dl or within 3x ULN for patients with Gilbert's disease Normal renal function: normal serum creatinine or measured creatinine clearance less than 50 mL/minute. Fasting cholesterol greater than or equal to 220 untreated
* be willing to not donate blood or semen for three months following discontinuation of Study medications.
* is willing to avoid pregnancy in his partner as defined by the following: Male subject is willin…
What they're measuring
1
Time to Recurrence to Baseline SEB Burden Following 7 Months of Continuous Vismodegib Treatment.
Timeframe: A Data Safety Monitoring Board (DSMB) will review results for an interim analysis when 12 subjects have completed 28 months.