A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
A Single-Arm, Open-Label, Expanded Access Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
1 other identifier
expanded_access
N/A
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2010
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 8, 2010
CompletedFirst Posted
Study publicly available on registry
July 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedAugust 6, 2015
August 1, 2015
1.8 years
July 8, 2010
August 4, 2015
Conditions
Interventions
Oral repeating dose
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (11)
Unknown Facility
Scottsdale, Arizona, 85258, United States
Unknown Facility
Scottsdale, Arizona, 85259, United States
Unknown Facility
Los Angeles, California, 90025, United States
Unknown Facility
Stanford, California, 94305, United States
Unknown Facility
Ormond Beach, Florida, 32174, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Houston, Texas, 77030, United States
Related Publications (1)
Chang AL, Arron ST, Migden MR, Solomon JA, Yoo S, Day BM, McKenna EF, Sekulic A. Safety and efficacy of vismodegib in patients with basal cell carcinoma nevus syndrome: pooled analysis of two trials. Orphanet J Rare Dis. 2016 Sep 1;11(1):120. doi: 10.1186/s13023-016-0506-z.
PMID: 27581207DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2010
First Posted
July 12, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
August 6, 2015
Record last verified: 2015-08