Clinical trial · Interventional
A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Oral Vismodegib for the Treatment of Basal Cell Carcinoma Preceding Excision by Mohs Micrographic Surgery
NCT01898598CI-TRIAL-00027410terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Vismodegib | Drug | Vismodegib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Vismodegib
- description
- Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
- interventionNames
- Drug: Vismodegib
Primary outcomes (1)
- measure
- Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma * Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site * Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements Exclusion Criteria: * Prior treatment with vismodegib * Known hypersensitivity to any of the study drug excipients * Any metastatic basal cell carcinoma * Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery * Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic) * Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination * Recent, current, or planned participation in another experimental drug study
References
Publications (0)
Data not yet available
No reference posted for this study.