Actively Recruiting
Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
34
Participants Needed
1
Research Sites
349 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to compare how well tolerated and effective four different dosing schedules (two personalized, intermittent dosing schedules as compared to a fixed intermittent and continuous dosing regimen) work in people with advanced basal cell carcinoma.
CONDITIONS
Official Title
Adaptive Therapy of Vismodegib in Advanced Basal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with cytologically or histologically confirmed locally advanced basal cell carcinoma (nodal involvement permitted)
- Adults 18 years of age or older at consent
- Ability and willingness to sign informed consent
- At least one skin tumor measurable by ruler or calipers
- Prior hedgehog inhibitor or systemic treatment allowed if more than 6 months ago
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Agreement not to donate blood or blood products during study and for 24 months after stopping vismodegib
- Adequate liver, kidney, and bone marrow function as defined in the protocol
- Negative pregnancy test within 7 days before dosing for premenopausal women
- Women of non-childbearing potential included if surgically sterile or postmenopausal for 1 year or more
- Women of reproductive potential must use two forms of contraception including one barrier method with spermicide during and for 24 months after therapy
- Female patients must agree not to become pregnant or breastfeed during and for 24 months after treatment
- Male patients must use condoms during sexual intercourse with female partners of reproductive potential during treatment and for 3 months after last dose
- Male patients must agree not to donate sperm during study and for 3 months after stopping vismodegib
You will not qualify if you...
- Received hedgehog inhibitor therapy within the last 6 months
- Female patients who are pregnant, intend to become pregnant, or are nursing
- Uncontrolled illnesses including serious infections
- Known history or symptoms of cardiac disease without clinical risk assessment
- Allergy or severe reaction to vismodegib or its ingredients
- Unable or unwilling to swallow capsules
- Co-treatment with statins or St. John's Wort
- Previous malignancy only excluded if not under control or receiving anti-cancer therapy, or if melanoma target lesions are unclear for assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33617
Actively Recruiting
Research Team
S
Sy Olson-Mcpeek
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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