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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02436408 |
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Date of registration:
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01/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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VISmodegib for ORbital and Periocular Basal Cell Carcinoma
VISORB |
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Scientific title:
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VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB) |
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Date of first enrolment:
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July 15, 2015 |
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Target sample size:
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35 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02436408 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Brenda Bohnsack, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients over 18 years of age with locally advanced or recurrent orbital or
periorbital basal cell carcinoma (BCCA), or a medial canthal BCCA that threatens the
lacrimal drainage system.
- Clinical assessment score obtained at baseline.
- Medical Oncology screening performed at baseline.
- Adequate BCCA size and location.
- Adequate hematopoietic capacity, hepatic and renal function.
- Male patients must agree to use condoms during treatment and for 3 months after last
dose.
- Male patients must agree to not donate sperm during treatment and for 3 months after
last dose.
- Participant must agree not to donate blood during the study and for 7 months after
last dose.
- Informed consent signed.
- If the patient consents to enroll, then blood will be drawn and stored for biomarker
analysis.
Exclusion Criteria:
- Inability or unwillingness to swallow capsules.
- Inability or unwillingness to comply with study procedures.
- Pregnant, lactating, or breast feeding women.
- Women of childbearing potential.
- Uncontrolled medical illness.
- Dementia or significantly altered mental status that would prohibit the understanding
or rendering of informed consent and compliance with the requirements of this
protocol.
- Age under 18 years.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Carcinoma, Basal Cell
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Intervention(s)
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Drug: Vismodegib
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Primary Outcome(s)
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The number of patients with a score of 21 or greater by the Visual Assessment Weighted Score (VAWS).
[Time Frame: Up to 15 months after start of study treatment]
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Secondary Outcome(s)
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Number of patients with a complete response (CR), partial response (PR) or stable disease (SD) AND good tolerance of vismodegib
[Time Frame: Up to 15 months after start of study treatment]
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Number of patients with progressive disease (PD)
[Time Frame: Up to 15 months after start of study treatment]
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Number of patients with a complete response (CR), partial response (PR) or stable disease (SD) AND poor tolerance of vismodegib
[Time Frame: Up to 15 months after start of study treatment]
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Secondary ID(s)
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HUM00082579
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UMCC 2014.022
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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