A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
27 de marzo de 2017 actualizado por: Hoffmann-La Roche
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
This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
18
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259
- Mayo Clinic
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California
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Beverly Hills, California, Estados Unidos, 90210
- Moy-Fincher-Chipps Facial Plastics and Dermatology
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La Jolla, California, Estados Unidos, 92037
- Scripps Clinic
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Loma Linda, California, Estados Unidos, 92354
- Loma Linda University Medical Center
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Palo Alto, California, Estados Unidos, 94305
- Stanford University
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San Francisco, California, Estados Unidos, 94107
- California Pacific Medical Center
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San Francisco, California, Estados Unidos, 94115
- Univ of Calif-San Francisco
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Florida
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St. Petersburg, Florida, Estados Unidos, 33716
- Spencer Derma & Skin Surg Ctr
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Indiana
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Carmel, Indiana, Estados Unidos, 46032
- Laser & Skin Surgery Center of Indiana
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota
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New York
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New York, New York, Estados Unidos, 10011
- Beth Israel Cancer Center; West Campus
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center; University Dermatology Associates
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West Islip, New York, Estados Unidos, 11795
- Mariwalla Dermatology
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27106
- The Skin Surgery Center
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Oregon
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Portland, Oregon, Estados Unidos, 97239-4501
- Oregon Health & Science University; Department of Dermatology
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Texas
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Houston, Texas, Estados Unidos, 77030-4095
- MD Anderson Cancer Center
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute at the University of Utah
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo
Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks.
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Participants will receive matching placebo to vismodegib for 12 weeks.
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Experimental: Vismodegib
Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
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Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit
Periodo de tiempo: Baseline, MMS visit (Week 12-14)
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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.
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Baseline, MMS visit (Week 12-14)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit
Periodo de tiempo: Baseline, MSS Visit (Week 12-14)
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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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Baseline, MSS Visit (Week 12-14)
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Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit
Periodo de tiempo: Baseline, MMS visit (Week 12-14)
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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.
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Baseline, MMS visit (Week 12-14)
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Percentage of Participants With Clinical Response
Periodo de tiempo: MMS visit (Week 12-14)
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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.
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MMS visit (Week 12-14)
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Percentage of Participants With Skip Area
Periodo de tiempo: MMS visit (Week 12-14)
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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.
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MMS visit (Week 12-14)
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Percentage of Participants With BCC Recurrence
Periodo de tiempo: Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)
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Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de enero de 2014
Finalización primaria (Actual)
26 de enero de 2016
Finalización del estudio (Actual)
26 de enero de 2016
Fechas de registro del estudio
Enviado por primera vez
3 de julio de 2013
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2013
Publicado por primera vez (Estimar)
12 de julio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de mayo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
27 de marzo de 2017
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ML28726
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .