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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to compare how well tolerated and effective four different dosing schedules (two personalized, intermittent dosing schedules as compared to a fixed intermittent and continuous dosing regimen) work in people with advanced basal cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Continuous Vismodegib | Active Comparator | Participants will receive continuous 150 mg by mouth daily vismodegib as per commercially available package insert. |
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| Arm B: Fixed Intermittent Vismodegib | Experimental | Participants will receive intermittent 150 mg dose vismodegib by mouth with a 12 weeks on/8 weeks off regimen. Participants will take vismodegib for first 12 weeks, then off 8 weeks, and alternate in fixed cycles. |
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| Arm C: Personalized Intermittent Vismodegib (Adaptive) | Experimental | Participants will start with an 8-week run in period with vismodegib 150 mg dose by mouth daily. Participants will take vismodegib for the first 8 weeks, then start personalized dosing based on specific model. |
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| Arm D: Personalized Intermittent Vismodegib (TGI model) | Experimental | Participants will start with an 8-week run in period with vismodegib 150 mg dose by mouth daily. Participants will take vismodegib for the first 8 weeks, then start personalized dosing based on TGI model. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vismodegib 150 MG Oral Capsule | Drug | Vismodegib is a hedgehog signalling pathway target agent. Participants will self-administer the standard 150 mg dose by mouth. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure | Time to treatment failure (defined as the time from the day of first dose of study drug to the first day of treatment with another regiment or with the same regimen in a non-adaptive fashion) or a personalized vs fixed intermittent vs continuous dosing of vismodegib. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall Response Rate (ORR) is defined as the rate of the best overall response as complete response (CR) or partial response (PR). ORR will be measured using composite response criteria using RECIST 1.1 and/or externally visible tumors evaluated by bi-dimensional digital medical photography (WHO criteria). | Up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sy Olson-Mcpeek | Contact | 813-745-0935 | sy.olson-mcpeek@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Zeynep Eroglu, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33617 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C538724 | HhAntag691 |
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