A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma

Completed · Phase 2

Conditions studied: Basal Cell Carcinoma

In brief

This is a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients receive vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.

Key facts

Study ID

NCT00833417

Run by

Genentech, Inc.

People needed

104

Starts

2009-02-10

Expected to finish

2014-04-09

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥ 18 years of age.
• For patients with metastatic basal cell carcinoma (BCC), histological confirmation of distant BCC metastasis (eg, lung, liver, lymph nodes, or bone), with metastatic disease that is Response Evaluation Criteria in Solid Tumors (RECIST) measurable using computed tomography (CT) or magnetic resonance imaging (MRI).
• For patients with locally advanced BCC, histologically confirmed disease that is considered to be inoperable.
• For patients with locally advanced BCC, radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate. For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
• For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of vismodegib (GDC-0449).
• For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of vismodegib.

You may not qualify if…

• Prior treatment with vismodegib or other Hedgehog pathway inhibitors.
• Pregnancy or lactation.
• Life expectancy of < 12 weeks.
• Patients with superficial multifocal BCC who may be considered unresectable due to breadth of involvement.
• Concurrent non-protocol-specified anti-tumor therapy (eg, chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy).
• Recent, current, or planned participation in an experimental drug study.
• History of other malignancies within 3 years of the first day of treatment with vismodegib in this study (Day 1), except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
• Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Angeles Clinic & Rsch Inst — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Univ of Calif-San Francisco — San Francisco, California, United States
• Univ of Colorado Hlth Sci Ctr — Aurora, Colorado, United States
• Advanced Derm & Cosmetic Surg — Ormond Beach, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Siouxland Hematology/Oncology — Sioux City, Iowa, United States
• Johns Hopkins Univ Med Center — Baltimore, Maryland, United States
• Massachusetts General Hospital. — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester; Medical Oncology — Rochester, Minnesota, United States
• VA Southern Nevada Healthcare — Las Vegas, Nevada, United States
• Dartmouth Hitchcock Med Center — Lebanon, New Hampshire, United States
• Mount Sinai School of Medicine; Dermatology — New York, New York, United States
• Univ No Carolina School of Med; Physicians Office Bldg — Chapel Hill, North Carolina, United States
• Arthur G. James Cancer Hosp — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Sarah Cannon Research Inst — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• St George Hospital — Kogarah, New South Wales, Australia
• Princess AleXandra Hospital; Department of Medical Oncology — Woolloongabba, Queensland, Australia
• Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia
• Institut Jules Bordet — Anderlecht, Belgium

Full record on ClinicalTrials.gov

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