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A Single-Arm, Open-Label, Expanded Access Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Basal Cell Carcinoma

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Trial Information

A Single-Arm, Open-Label, Expanded Access Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma


Inclusion Criteria:



- For patients with mBCC, histologic confirmation of distant BCC metastasis

- For patients with locally advanced BCC, at least one histologically confirmed lesion
10 mm or more in diameter and written confirmation from a surgical specialist that
the tumor is considered inoperable or that surgery is contraindicated

- For patients with locally advanced BCC, radiotherapy must have been previously
administered for locally advanced BCC, unless radiotherapy is contraindicated or
inappropriate. For patients whose locally advanced BCC has been irradiated, disease
must have progressed after radiation.

- Patients with Gorlin syndrome may enroll in this study but must meet the criteria for
locally advanced or metastatic disease listed above

- Patients with measurable and/or non-measurable disease (as defined by RECIST) are
allowed

- Adequate organ function

- 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
(GDC-0449)

Exclusion Criteria:

- Pregnancy or lactation

- Life expectancy < 12 weeks

- Concurrent non-protocol-specified anti-tumor therapy

- Completion of most recent anti-tumor therapy at least 21 days prior to initiation of
treatment

- Uncontrolled medical illnesses such as infection requiring treatment with intravenous
antibiotics

- History of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates use of an investigational drug or that might affect
interpretation of the results of the study or renders the patient at high risk from
treatment complications

- Unwillingness to practice effective birth control

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Diana M. Chen, MD, FAAD

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

SHH4811g

NCT ID:

NCT01160250

Start Date:

July 2010

Completion Date:

April 2012

Related Keywords:

  • Basal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location

Investigational SiteDuarte, California  91010-3000
Investigational SiteLansing, Michigan  48912
Investigational SiteSan Antonio, Texas  78229
Investigational SiteOcala, Florida  
Investigational SiteNashville, Tennessee  37203
Investigational SiteScottsdale, Arizona  85258