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VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)

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ClinicalTrials.gov Identifier: NCT02436408
Recruitment Status : Active, not recruiting
First Posted : May 6, 2015
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Tracking Information
First Submitted Date  ICMJE May 1, 2015
First Posted Date  ICMJE May 6, 2015
Last Update Posted Date April 30, 2020
Actual Study Start Date  ICMJE July 15, 2015
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
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 ]
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. Patients will be assessed at 1 year after start of study treatment or 2 (+/- 1) months after tumor excision/debulking surgery, whichever is longer.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2015)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
  • Number of patients with progressive disease (PD) [ Time Frame: Up to 15 months after start of study treatment ]
    Treatment response will be determined per Response Evaluation Criteria in Solid Tumors (RECIST) protocol, using clinical measurements and/or tumor imaging measurements (determined by treating physician).
  • 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 ]
    Treatment response will be determined per RECIST, using clinical measurements and/or tumor imaging measurements (determined by treating physician). Tolerance will be self-reported by patient.
  • 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 ]
    Treatment response will be determined per RECIST, using clinical measurements and/or tumor imaging measurements (determined by treating physician). Tolerance will be self-reported by patient.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VISmodegib for ORbital and Periocular Basal Cell Carcinoma
Official Title  ICMJE VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)
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.

Patients with tumors that do not respond to treatment with Vismodegib, and those who have a good response but poor tolerance of Vismodegib, will be offered surgical excision of the tumor. Patients with a good response and good tolerance of Vismodegib may continue the treatment as long as clinically indicated.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Basal Cell
Intervention  ICMJE Drug: Vismodegib
Study Arms  ICMJE Experimental: Vismodegib
150mg taken orally once daily
Intervention: Drug: Vismodegib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 4, 2019)
35
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2015)
50
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02436408
Other Study ID Numbers  ICMJE UMCC 2014.022
HUM00082579 ( Other Identifier: University of Michigan )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Michigan Rogel Cancer Center
Study Sponsor  ICMJE University of Michigan Rogel Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brenda Bohnsack, M.D., Ph.D. University of Michigan
PRS Account University of Michigan Rogel Cancer Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP