Clinical trial NCT01898598: A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Oral Vismodegib for the Treatment of Basal Cell Carcinoma Preceding Excision by Mohs Micrographic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Basal Cell Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
* Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
* Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements

Exclusion Criteria:

* Prior treatment with vismodegib
* Known hypersensitivity to any of the study drug excipients
* Any metastatic basal cell carcinoma
* Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
* Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
* Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
* Recent, current, or planned participation in another experimental drug study

Primary outcomes:
measure: Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit
timeFrame: Baseline, MMS visit (Week 12-14)
Secondary outcomes:
measure: Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit
timeFrame: Baseline, MSS Visit (Week 12-14)
measure: Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit
timeFrame: Baseline, MMS visit (Week 12-14)
measure: Percentage of Participants With Clinical Response
timeFrame: MMS visit (Week 12-14)
measure: Percentage of Participants With Skip Area
timeFrame: MMS visit (Week 12-14)
measure: Percentage of Participants With BCC Recurrence
timeFrame: Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Beverly Hills
country: United States
facility: Moy-Fincher-Chipps Facial Plastics and Dermatology
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: Univ of Calif-San Francisco
state: California
city: St. Petersburg
country: United States
facility: Spencer Derma & Skin Surg Ctr
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Carmel
country: United States
facility: Laser & Skin Surgery Center of Indiana
state: Indiana
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Beth Israel Cancer Center; West Campus
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center; University Dermatology Associates
state: New York
city: West Islip
country: United States
facility: Mariwalla Dermatology
state: New York
city: Winston-Salem
country: United States
facility: The Skin Surgery Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University; Department of Dermatology
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at The University of Utah
state: Utah
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: