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Trial record 33 of 78 for:    vismodegib

VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)

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ClinicalTrials.gov Identifier: NCT02436408
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:

Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat.

Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is eventually required

In order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCCA, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with vismodegib as standard of care.


Condition or disease Intervention/treatment Phase
Carcinoma, Basal Cell Drug: Vismodegib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)
Study Start Date : May 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

Arm Intervention/treatment
Experimental: Vismodegib
150mg taken orally once daily
Drug: Vismodegib



Primary Outcome Measures :
  1. The number of patients with a score of 21 or greater by the Visual Assessment Weighted Score (VAWS) at 1 year [ Time Frame: 1 year ]
    The VAWS was developed for the purpose of this study. It is made up of standard ophthalmic exam points, as well as subjective assessment of tearing and overall patient satisfaction. The maximum score is 50 and a score of 21 or greater will be considered a good outcome



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436408


Contacts
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Contact: Alon Kahana, M.D.. Ph.D. 734-936-8654 akahana@med.umich.edu

Locations
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United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Alon Kahana, M.D., Ph.D.    734-936-8654    akahana@med.umich.edu   
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Alon Kahana, M.D., Ph.D. University of Michigan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02436408     History of Changes
Other Study ID Numbers: UMCC 2014.022
HUM00082579 ( Other Identifier: University of Michigan )
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell