A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

August 4, 2015 updated by: Genentech, Inc.

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

This is an open-label, non-comparative, multicenter, expanded access study of Vismodegib (GDC-0449) in patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC (mBCC) who are otherwise without satisfactory treatment options.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
      • Scottsdale, Arizona, United States, 85259
    • California
      • Los Angeles, California, United States, 90025
      • Stanford, California, United States, 94305
    • Florida
      • Ormond Beach, Florida, United States, 32174
    • Michigan
      • Detroit, Michigan, United States, 48201
    • New York
      • New York, New York, United States, 10029
    • Ohio
      • Columbus, Ohio, United States, 43210
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (Estimate)

July 12, 2010

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHH4811g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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