A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma

Phase 2TerminatedNCT01898598

Hoffmann-La Roche18 enrolled

Overview

This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Basal Cell Carcinoma

Interventions

PlaceboDRUG

Participants will receive matching placebo to vismodegib for 12 weeks.

VismodegibDRUG

Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Mayo Clinic

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit

The percent change in target BCC expected surgical defect area was defined as (\[baseline expected surgical defect area - expected surgical defect area at MMS visit\]/ baseline expected surgical defect area) × 100 percent (%) where expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.

Time frame: Baseline, MMS visit (Week 12-14)

Secondary Outcomes

Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit

Actual change was defined as (baseline expected surgical defect area - expected surgical defect area at MMS visit). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment. Expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry).

Time frame: Baseline, MSS Visit (Week 12-14)

Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit

Percent change in target BCC actual tumor-free margin excision area was defined as = (expected surgical defect area pre-treatment - actual tumor-free margin excision area at MMS visit) / expected surgical defect area pre-treatment) \* 100%. The actual tumor-free margin excision area (includes 2 millimeters \[mm\] margin) was measured during MMS. The area was photographed and traced on the digital photograph then calculated by computer-aided planimetry. MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.

Time frame: Baseline, MMS visit (Week 12-14)

Percentage of Participants With Clinical Response

Clinical response was defined as a complete response (CR) or partial response (PR) at the post-treatment MMS excision. CR was defined as no histological evidence of BCC. PR was defined as a reduction of at least 50 % in the expected surgical defect area with histologic evidence of residual BCC. MMS visit was defined the visit that occurred within 2 weeks of the last study treatment.

Data from ClinicalTrials.gov

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