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

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Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01160250
First received: July 8, 2010
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Basal Cell Carcinoma
Drug: Vismodegib (GDC-0449)
Phase 2

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Single-Arm, Open-Label, Expanded Access Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Genentech:

Study Start Date: July 2010
Study Completion Date: April 2012
Intervention Details:
    Drug: Vismodegib (GDC-0449)
    Oral repeating dose
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160250

Locations
United States, Arizona
Investigational Site
Scottsdale, Arizona, United States, 85258
Investigational Site
Scottsdale, Arizona, United States, 85259
United States, California
Investigational Site
Los Angeles, California, United States, 90025
Investigational Site
Santa Monica, California, United States, 90404
Investigational Site
Stanford, California, United States, 94305
United States, Florida
Investigational Site
Ormond Beach, Florida, United States, 32174
United States, Michigan
Investigational Site
Detroit, Michigan, United States, 48201
United States, Tennessee
Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Investigational Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Genentech
Investigators
Study Director: Diana M. Chen, MD, FAAD Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01160250     History of Changes
Other Study ID Numbers: SHH4811g
Study First Received: July 8, 2010
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on August 28, 2014