MedTrace Logo

Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas

NCT01556009 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-11-02

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate and compare the safety and efficacy of intermittent vismodegib and of Photodynamic Therapy (PDT).

Conditions

  • Basal Cell Nevus Syndrome
  • Gorlin's Syndrome

Interventions

DRUG

Vismodegib

150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.

DRUG

Aminolevulinic acid %20 topical solution

20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • UCSF Benioff Children's Hospital Oakland

    lead OTHER

Principal Investigators

  • Ervin Epstein, MD · Children's Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01556009 on ClinicalTrials.gov