Trial Search Results

A Study of Two Vismodegib Regimens in Participants 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 participants with multiple basal cell carcinoma. Participants 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 currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Intervention(s):

  • Drug: Vismodegib
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Adult participants, >/= 18 years of age

   - Participants with multiple basal cell carcinomas, including participants 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 9 months after completion of study treatment

   - Male participants 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

Exclusion Criteria:

   - Inability or unwillingness to swallow capsules

   - Pregnant or breastfeeding women

   - Any metastatic basal cell carcinoma

   - Locally advanced basal cell carcinoma lesion that is considered to be inoperable or to
   have medical contraindications to surgery

   - Recent (i.e., within the past 28 days prior to randomization) or current participation
   in another experimental drug study

   - Known or suspected alcohol abuse

   - One of the following known rare hereditary conditions: galactose intolerance, primary
   hypolactasia or glucose-galactose malabsorption

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting