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Trial record 9 of 78 for:    vismodegib

Vismodegib for Treatment of Basal Cell Carcinoma (Erivedge)

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ClinicalTrials.gov Identifier: NCT01543581
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : September 26, 2014
Last Update Posted : September 26, 2014
Sponsor:
Information provided by (Responsible Party):
Abel Torres, MD, Loma Linda University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Basal Cell Carcinoma
Interventions Drug: Vismodegib
Drug: Placebo
Enrollment 3
Recruitment Details The dates of the recruitment period in this study were Dec. 12,2011 through November 2012. Prospective subjects were seen in Loma Linda University Dermatology Clinic and were also seen prior to being referred to Loma Linda at Riverside County Regional Medical Clinic.
Pre-assignment Details One subject signed the consent and was enrolled and completed the study. Two others signed the consent but were unable to continue their enrollment as one found out that he had Parkinsons Disease and the other could not arrange for transportation.
Arm/Group Title Vismodegib Inactive Placebo
Hide Arm/Group Description Those to whom the drug is given. Those to whom the inactive placebo is given.
Period Title: Overall Study
Started 1 0
Completed 1 0
Not Completed 0 0
Arm/Group Title Vismodegib
Hide Arm/Group Description Oral vismodegib, 150mg per day for 12 weeks.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
00
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
00
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Mohs Micrographic Surgery (MMS)
Hide Description The final wound size taken immediately after the completion of Mohs surgery (i.e., upon reaching tumor-free tissue margins) was determined using pre treatment lesion outlined plus one additional concentric 2mm margin removed to establish an objective consistent measure for wound size. The diameter of the final wound size was measured in mm.
Time Frame The Mohs surgical excision of the target tumor was performed within two weeks, after the last day of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib
Hide Arm/Group Description:
Oral vismodegib, 150mg per day for 12 weeks.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: mm
1
2.Secondary Outcome
Title Complete Response Rate
Hide Description A secondary variable is the complete response rate, defined as the proportion of patients with no histological evidence of basal cell carcinoma on the post treatment MMS excision of the target tumor area. For this analysis, the placebo data will be pooled together to calculate the complete response rate for the placebo group.
Time Frame 12 to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vismodegib
Hide Arm/Group Description:
Those to whom the drug is given.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
1
Time Frame 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vismodegib Inactive Placebo
Hide Arm/Group Description Oral vismodegib, 150mg per day for 12 weeks. Those to whom the inactive placebo is given.
All-Cause Mortality
Vismodegib Inactive Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vismodegib Inactive Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vismodegib Inactive Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/0    
Blood and lymphatic system disorders     
Elevated AST   1/1 (100.00%)  1 0/0  0
Gastrointestinal disorders     
loss of taste sensation   1/1 (100.00%)  1 0/0  0
Musculoskeletal and connective tissue disorders     
leg cramps   1/1 (100.00%)  1 0/0  0
Respiratory, thoracic and mediastinal disorders     
Chest Cold   1/1 (100.00%)  1 0/0  0
Upper Respiratory Infection   1/1 (100.00%)  1 0/0  0
Skin and subcutaneous tissue disorders     
MRSA recurrence   1/1 (100.00%)  1 0/0  0
hair loss   1/1 (100.00%)  1 0/0  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Abel Torres, PI
Organization: Loma Linda University Health, Department of Dermatology
Phone: (909) 558-2055
Responsible Party: Abel Torres, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01543581     History of Changes
Other Study ID Numbers: 5110325
First Submitted: February 14, 2012
First Posted: March 5, 2012
Results First Submitted: September 19, 2013
Results First Posted: September 26, 2014
Last Update Posted: September 26, 2014