A Randomized, Double-blinded, Regimen-controlled, Phase II, Multicenter Study to Assess the Efficacy and Safety of Two Different Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas
This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinoma. Patients will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : vismodegib
- drug : placebo
- drug : vismodegib
Phase: Phase 2
Ages Eligible For Study:
- Adult patients, >/= 18 years of age - Patients with multiple basal cell carcinomas, including patients with Gorlin syndrome, with at least 6 clinically evident basal cell carcinomas at the time of randomization, of which 3 measure 5 mm or more in diameter and are considered target lesions. All other lesions are considered to be non-target lesions - Histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 - Adequate renal and hepatic function and hematopoietic capacity - Women of childbearing potential must agree to use contraception as defined by protocol during treatment and for at least 7 months after completion of study treatment - Male patients with female partners of childbearing potential must agree to use contraception as defined by protocol during treatment and for 2 months after completion of study treatment