Status:
COMPLETED
A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) in Patients With Advanced Basal Cell Carcinoma
Lead Sponsor:
Genentech, Inc.
Conditions:
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was 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 received...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00833417
Start Date
February 1 2009
End Date
April 1 2014
Last Update
May 20 2015
Active Locations (35)
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1
Scottsdale, Arizona, United States, 85259
2
Los Angeles, California, United States, 90025
3
San Francisco, California, United States, 94115
4
Stanford, California, United States, 94305