Neoplasms

All Conditions

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.

Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.

Participants will receive matching placebo to vismodegib for 12 weeks.

Placebo

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

Vismodegib

Clinical Trials

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

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

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.

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).

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.

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.

Skip area was defined as the presence of non-contiguous residual tumor at the MMS visit, as determined by an independent dermatopathologist. MMS visit occurred within 2 weeks of the last study treatment.

Hoffmann-La Roche

Safety population, included all participants who received at least one dose of study treatment.

Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.

Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.

Total

Age, Continuous

Sex: Female, Male

The Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study treatment.

The study was discontinued early by the Sponsor and due to a small sample size, no conclusions can be drawn.

Medical Communications

ITT population. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.

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

ITT Population. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.

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

ITT. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.

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

The 95 % confidence interval (CI) for the difference in response rates was computed using the exact unconditional confidence limits method.

Percentage of Participants With Clinical Response

Percentage of Participants With Skip Area

This outcome was based on the cumulative data post MMS Visit and due to early study termination with very few enrolled participants, complete data for this outcome measure could not be collected.

Percentage of Participants With BCC Recurrence

Participants received vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.

Spots Global Cancer Trial Database for A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma

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Interventions

Study Description

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