Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02436408
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : October 28, 2021
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Basal Cell
Intervention Drug: Vismodegib
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vismodegib
Hide Arm/Group Description 150mg taken orally once daily
Period Title: Overall Study
Started 35
Completed 34
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title Vismodegib
Hide Arm/Group Description 150mg taken orally once daily
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants
69
(45 to 95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
17
  48.6%
Male
18
  51.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
34
  97.1%
Unknown or Not Reported
1
   2.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title The Number of Patients With a Score of 21 or Greater by the Visual Assessment Weighted Score (VAWS).
Hide Description 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.
Time Frame Until end of study treatment (up to 15 months after start of study treatment); treatment duration ranged from 53 - 386 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib
Hide Arm/Group Description:
150mg taken orally once daily
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
34
 100.0%
2.Secondary Outcome
Title Number of Patients With Progressive Disease (PD)
Hide Description 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).
Time Frame Until end of study treatment (up to 15 months after start of study treatment); treatment duration ranged from 53 - 386 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib
Hide Arm/Group Description:
150mg taken orally once daily
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Number of Patients With a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) AND Good Tolerance of Vismodegib
Hide Description Tolerance will be self-reported by patient. 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).
Time Frame Until end of study treatment (up to 15 months after start of study treatment); treatment duration ranged from 53 - 386 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib
Hide Arm/Group Description:
150mg taken orally once daily
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
7
  20.6%
4.Secondary Outcome
Title Number of Patients With a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) AND Poor Tolerance of Vismodegib
Hide Description Tolerance will be self-reported by patient. 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).
Time Frame Until end of study treatment (up to 15 months after start of study treatment); treatment duration ranged from 53 - 386 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib
Hide Arm/Group Description:
150mg taken orally once daily
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
27
  79.4%
Time Frame Up to 15 months after start of study treatment; data was collected on study for 62 months total
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vismodegib
Hide Arm/Group Description 150mg taken orally once daily
All-Cause Mortality
Vismodegib
Affected / at Risk (%)
Total   2/35 (5.71%) 
Hide Serious Adverse Events
Vismodegib
Affected / at Risk (%)
Total   9/35 (25.71%) 
Cardiac disorders   
Acute coronary syndrome   1/35 (2.86%) 
Heart failure   1/35 (2.86%) 
Gastrointestinal disorders   
Colitis   1/35 (2.86%) 
Gastrointestinal disorders - Other   1/35 (2.86%) 
Nausea   2/35 (5.71%) 
Vomiting   2/35 (5.71%) 
Infections and infestations   
Infections and infestations - Other   1/35 (2.86%) 
Lung infection   2/35 (5.71%) 
Sepsis   1/35 (2.86%) 
Metabolism and nutrition disorders   
Hypoglycemia   1/35 (2.86%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other   1/35 (2.86%) 
Renal and urinary disorders   
Acute kidney injury   1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders   
Aspiration   1/35 (2.86%) 
Pulmonary edema   1/35 (2.86%) 
Skin and subcutaneous tissue disorders   
Skin and subcutaneous tissue disorders - Other   1/35 (2.86%) 
Vascular disorders   
Vascular disorders - Other   1/35 (2.86%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vismodegib
Affected / at Risk (%)
Total   34/35 (97.14%) 
Blood and lymphatic system disorders   
Anemia   2/35 (5.71%) 
Cardiac disorders   
Sinus bradycardia   1/35 (2.86%) 
Ear and labyrinth disorders   
Hearing impaired   1/35 (2.86%) 
Tinnitus   1/35 (2.86%) 
Eye disorders   
Blurred vision   1/35 (2.86%) 
Cataract   2/35 (5.71%) 
Dry eye   1/35 (2.86%) 
Eye disorders - Other   8/35 (22.86%) 
Eye pain   1/35 (2.86%) 
Eyelid function disorder   3/35 (8.57%) 
Watering eyes   3/35 (8.57%) 
Gastrointestinal disorders   
Abdominal pain   2/35 (5.71%) 
Constipation   6/35 (17.14%) 
Diarrhea   3/35 (8.57%) 
Gastroesophageal reflux disease   5/35 (14.29%) 
Nausea   11/35 (31.43%) 
Vomiting   4/35 (11.43%) 
General disorders   
Chills   1/35 (2.86%) 
Edema face   2/35 (5.71%) 
Edema limbs   1/35 (2.86%) 
Fatigue   12/35 (34.29%) 
Fever   1/35 (2.86%) 
General disorders and administration site conditions - Other   1/35 (2.86%) 
Pain   4/35 (11.43%) 
Infections and infestations   
Papulopustular rash   2/35 (5.71%) 
Injury, poisoning and procedural complications   
Bruising   1/35 (2.86%) 
Fall   2/35 (5.71%) 
Investigations   
Alanine aminotransferase increased   1/35 (2.86%) 
Alkaline phosphatase increased   1/35 (2.86%) 
Aspartate aminotransferase increased   1/35 (2.86%) 
Creatinine increased   1/35 (2.86%) 
Weight loss   12/35 (34.29%) 
Metabolism and nutrition disorders   
Anorexia   12/35 (34.29%) 
Hyperglycemia   2/35 (5.71%) 
Hyperkalemia   1/35 (2.86%) 
Musculoskeletal and connective tissue disorders   
Arthralgia   3/35 (8.57%) 
Arthritis   2/35 (5.71%) 
Back pain   4/35 (11.43%) 
Generalized muscle weakness   5/35 (14.29%) 
Muscle weakness lower limb   3/35 (8.57%) 
Musculoskeletal and connective tissue disorder - Other   2/35 (5.71%) 
Myalgia   23/35 (65.71%) 
Pain in extremity   1/35 (2.86%) 
Nervous system disorders   
Dizziness   3/35 (8.57%) 
Dysgeusia   26/35 (74.29%) 
Facial muscle weakness   1/35 (2.86%) 
Peripheral motor neuropathy   1/35 (2.86%) 
Spasticity   7/35 (20.00%) 
Psychiatric disorders   
Agitation   1/35 (2.86%) 
Hallucinations   1/35 (2.86%) 
Insomnia   2/35 (5.71%) 
Libido decreased   1/35 (2.86%) 
Reproductive system and breast disorders   
Erectile dysfunction   1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/35 (2.86%) 
Epistaxis   1/35 (2.86%) 
Nasal congestion   4/35 (11.43%) 
Productive cough   1/35 (2.86%) 
Sinus disorder   1/35 (2.86%) 
Skin and subcutaneous tissue disorders   
Alopecia   17/35 (48.57%) 
Photosensitivity   1/35 (2.86%) 
Pruritus   1/35 (2.86%) 
Rash maculo-papular   1/35 (2.86%) 
Skin and subcutaneous tissue disorders - Other   4/35 (11.43%) 
Skin ulceration   2/35 (5.71%) 
Urticaria   1/35 (2.86%) 
Surgical and medical procedures   
Surgical and medical procedures - Other   1/35 (2.86%) 
Vascular disorders   
Hypotension   1/35 (2.86%) 
Indicates events were collected by systematic assessment
The initial study design aimed to enroll 50 patients; however, the study was terminated early as a consequence of the therapeutic and administrative challenges posed by the novel coronavirus pandemic and because the interim analysis revealed that the study at the point of termination was sufficient to achieve statistical significance.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cagri Besirli, MD, PhD
Organization: University of Michigan Rogel Cancer Center
Phone: 734-232-8404
EMail: cbesirli@med.umich.edu
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02436408    
Other Study ID Numbers: UMCC 2014.022
HUM00082579 ( Other Identifier: University of Michigan )
First Submitted: May 1, 2015
First Posted: May 6, 2015
Results First Submitted: September 29, 2021
Results First Posted: October 28, 2021
Last Update Posted: October 28, 2021