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This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks. |
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| Vismodegib | Experimental | Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will receive matching placebo to vismodegib for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, MMS visit (Week 12-14) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States | ||
| Moy-Fincher-Chipps Facial Plastics and Dermatology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vismodegib | Participants received vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks. |
| FG001 | Placebo | Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Vismodegib |
| Drug |
Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks |
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| 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. | 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. | MMS visit (Week 12-14) |
| Percentage of Participants With Skip Area | 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. | MMS visit (Week 12-14) |
| Percentage of Participants With BCC Recurrence | Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14) |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Scripps Clinic | La Jolla | California | 92037 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Stanford University | Palo Alto | California | 94305 | United States |
| California Pacific Medical Center | San Francisco | California | 94107 | United States |
| Univ of Calif-San Francisco | San Francisco | California | 94115 | United States |
| Spencer Derma & Skin Surg Ctr | St. Petersburg | Florida | 33716 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Laser & Skin Surgery Center of Indiana | Carmel | Indiana | 46032 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Beth Israel Cancer Center; West Campus | New York | New York | 10011 | United States |
| University of Rochester Medical Center; University Dermatology Associates | Rochester | New York | 14642 | United States |
| Mariwalla Dermatology | West Islip | New York | 11795 | United States |
| The Skin Surgery Center | Winston-Salem | North Carolina | 27106 | United States |
| Oregon Health & Science University; Department of Dermatology | Portland | Oregon | 97239-4501 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030-4095 | United States |
| Huntsman Cancer Institute at The University of Utah | Salt Lake City | Utah | 84112 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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The Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vismodegib | Participants received vismodegib 150 mg capsule orally once daily for 12 weeks. |
| BG001 | Placebo | Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT population. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change in surgical defect area | Baseline, MMS visit (Week 12-14) |
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| Secondary | 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). | ITT Population. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Square millimeter (mm^2) | Baseline, MSS Visit (Week 12-14) |
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| Secondary | 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. | ITT. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change in margin excision area | Baseline, MMS visit (Week 12-14) |
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| Secondary | 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. | ITT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | MMS visit (Week 12-14) |
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| Secondary | Percentage of Participants With Skip Area | 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. | ITT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | MMS visit (Week 12-14) |
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| Secondary | Percentage of Participants With BCC Recurrence | 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. | Posted | Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14) |
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Baseline up to 52 weeks after last study treatment (Last Study Treatment = Week 12)
Safety population, included all participants who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vismodegib | Participants received vismodegib 150 mg capsule orally once daily for 12 weeks. | 3 | 11 | 9 | 11 | ||
| EG001 | Placebo | Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks. | 0 | 5 | 2 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v18.1 | Non-systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v18.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA v18.1 | Non-systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA v18.1 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA v18.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Ageusia | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Nerve compression | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v18.1 | Non-systematic Assessment |
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The study was discontinued early by the Sponsor and due to a small sample size, no conclusions can be drawn.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
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| ID | Term |
|---|---|
| C538724 | HhAntag691 |
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| Male |
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