18 and older, any sex, with Basal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Efficacy of VismodegibPrimary· Week 24
The efficacy of vismodegib was defined as the number of tumor biopsies with positive pathology after 24 weeks. Subjects had one target lesion and up to 3 additional non-target lesions. A cumulative total of 65 tumors was measured after 24 weeks of treatment. Histopathological subtypes were categorized primarily as infiltrative, nodular and superficial.
Infiltrative
Group
Value
95% CI
Open Label Oral Vismodegib
2
Nodular
Group
Value
95% CI
Open Label Oral Vismodegib
5
Superficial
Group
Value
95% CI
Open Label Oral Vismodegib
1
Keratotic
Group
Value
95% CI
Open Label Oral Vismodegib
1
Safety of VismodegibSecondary· Up to 18 months
The safety of Vismodegib was evaluated by monitoring adverse effects. All adverse events, expected and unexpected, were recorded and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) guide. This is a set of criteria from the National Cancer Institute (NCI) used to standardize classification of adverse effects of drugs. Grade 1 events are defined as mild, grade 2 as moderate, grade 3 as severe; grade 4 as life-threatening and grade 5 as death.
Grade 1
Group
Value
95% CI
Open Label Oral Vismodegib
133
Grade 2
Group
Value
95% CI
Open Label Oral Vismodegib
48
Grade 3
Group
Value
95% CI
Open Label Oral Vismodegib
8
Grade 4
Group
Value
95% CI
Open Label Oral Vismodegib
1
Grade 5
Group
Value
95% CI
Open Label Oral Vismodegib
2
Onset of Efficacy of VismodegibSecondary· Up to week 24
Onset of efficacy was measured by tumor surface area reduction or increase. Subjects had one target lesion and up to 3 additional non-target lesions. Surface area of a cumulative total of 65 tumors (27 target lesions and 38 non-target lesions) was measured after 24 weeks of treatment. A complete response was defined as 100% reduction in tumor surface area. Partial response was defined as greater than 50% reduction in tumor surface area. Stable disease was defined as less than 50% reduction in tumor surface area and Progressive disease was defined as greater than 20% increase in tumor surface a
Complete response
Group
Value
95% CI
Open Label Oral Vismodegib
13
Partial response
Group
Value
95% CI
Open Label Oral Vismodegib
27
Stable Disease
Group
Value
95% CI
Open Label Oral Vismodegib
24
Progressive Disease
Group
Value
95% CI
Open Label Oral Vismodegib
1
Adverse events — posted to ClinicalTrials.gov
Time frame: The study period during which all Adverse Events (AE) and Serious Adverse Events (SAE) must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier..
Reporting threshold: 4%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to investigate the safety and effectiveness of oral vismodegib therapy in the treatment of different 'histologic subtypes' of basal cell skin cancer (BCC). The term 'histologic subtype' refers to how the cells and tumor tissue looks under the microscope. Three different 'histologic subtypes' of basal cell skin cancer (infiltrative/morpheaform, nodular and superficial) will be examined in this study.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07182240 — Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Ba
· NA
· recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr
· Phase 2
· recruiting
NCT06600165 — Intraoperative Confocal Laser Scanning Microscopy With Use of AI for Optimized Surgical Excision of Basal Cell Carcinoma
· recruiting
NCT06384924 — Raman Spectroscopy and Skin Cancer
· recruiting
NCT06384053 — Skin Cancer and Hyperthermia and Radiotherapy
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 23 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01700049.