Vismodegib for Treatment of Basal Cell Carcinoma (Erivedge)
This study is not yet open for participant recruitment.
Verified April 2012 by Loma Linda University
Information provided by (Responsible Party):
Loma Linda University
First received: February 14, 2012
Last updated: April 17, 2012
Last verified: April 2012
The primary objectives of this study are to assess, using Mohs micrographic surgery (MMS) at the end of treatment, the efficacy (primary) and safety (secondary) of vismodegib compared to placebo in the oral adjunctive pre surgical treatment of basal cell carcinoma. A secondary objective is to assess how often and in what types of lesions does pre surgical treatment with vismodegib result in complete eradication of the tumor.
Basal Cell Carcinoma
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||Placebo-controlled, Double Blind Study to Assess Efficacy and Safety of Oral Vismodegib for the Treatment of Basal Cell Carcinoma Preceding Excision by Mohs Micrographic Surgery (MMS)
Primary Outcome Measures:
- Mohs Micrographic Surgery (MMS) [ Time Frame: The Mohs surgical ecision of the target tumor will be performed witin two weeks, after the last day of treatment. ] [ Designated as safety issue: No ]
The final wound size at the completion of Mohs surgery (i.e., upon reaching tumor-free tissue margins) will be determined using pre treatment lesion outlined plus any additional concentric 2mm margins removed to establish an objective consistent measure for wound size , and compared to the wound sizes of similar MMS excised lesions in the placebo arm. In addition, the histological extent of the lesion will be compared to the expected subclinical extension as documented in the literature by Wolf and Zitelli.
Secondary Outcome Measures:
- Complete Response Rate [ Time Frame: 12 to 14 weeks ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
Active Comparator: Vismodegib
Those to whom the drug is given.
Oral vismodegib, 150mg per day for 12 weeks.
Other Name: Erivedge
Placebo Comparator: Inactive placebo
Those to whom the inactive placebo is given.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Willing and able to give informed consent.
- At least 18 years of age.
Have a confirmed BCC at one of listed anatomical sites which must be biopsy-confirmed at the study site and meets this criteria:
- minimum tumor area of 0.5 cm2 in an anatomic location at risk for significant deformity or functional impairment with surgery.
- macroscopically (clinically) consistent with BCC
- histologically consistent with BCC
- suitable for treatment with Mohs surgical excision
- identifiable by subject or reliable subject representative
- Free of any significant physical abnormalities (e.g., tattoos) at treatment site.
Willing and able to participate in the study as an outpatient, making frequent visits to clinic during treatment and follow-up periods and comply with study requirements, including:
- Consenting to biopsy of the lesion at baseline, if needed, before beginning study drug treatment
- Attend all scheduled clinic visits during pre-study, treatment, and follow-up periods
- Will delay excision of the target tumor site until time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability
- Post-excisional follow-up visits until the area is healed to investigator's satisfaction
- Female of reproductive potential must use 2 forms of acceptable contraception (including one acceptable barrier method with spermicide) during therapy and for 7 months after completing therapy.
- Male patients must use condoms at all times, with spermicide, even after vasectomy, during sexual intercourse with females during treatment and for 2 months after the last dose.
- Agrees not to donate blood or blood products during the study and for 7 months after last dose.
- Prior treatment with GDC-0449 or any HH Pathway Inhibitor
- Have evidence of clinically significant, unstable cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease. Subjects with clinically stable medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or osteoarthritis, will be allowed to enter the study.
- Have any dermatological disease at treatment site that may be exacerbated by treatment with vismodegib or cause difficulty with examination (e.g., psoriasis, eczema).
- Inability or unwillingness to swallow capsules
- Pregnancy or lactation
- Have a desire to conceive in the future.
- Patients with known Gorlin's (basal cell nevus) syndrome or clinical suspicion of Gorlin's Syndrome)
- Recent (i.e., within the past 28 days), current, or planned participation in another experimental drug study
- Have active chemical dependency or alcoholism..
Have received following treatments for BCC in the treatment area within designated time period before study treatment initiation:
Treatment Time Period:
Prescribed topical retinoids 4 weeks Surgical excision 4 weeks Curettage 4 weeks Cryo destruction or chemo destruction 4 weeks
- Received treatment for non-melanoma skin cancer or precancerous condition [squamous cell carcinoma (SCC), or actinic keratosis (AK)] within treatment area within 4 weeks of study treatment initiation, or currently have SCC, malignant melanoma (MM), or any other dermatological condition in treatment area that requires treatment.
- Received any cancer chemotherapy within 6 months before study treatment initiation (subject must not currently have any evidence of cancer, other than skin cancer).
Received any of the following treatments within 4 weeks before study treatment initiation:
- Interferon or interferon inducers
- Immunomodulators or immunosuppressive therapies
- Cytotoxic drugs
- Investigational drugs
- Drugs known to have major organ toxicity
- Oral corticosteroids
- Inhaled corticosteroids (> 1200 Xg/day for beclomethasone, or > 600 Xg/day for fluticasone)
- Topical steroids in treatment area
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543581
|Faculty Medical Offices
|Loma Linda, California, United States, 92354 |
|Contact: Abel Torres, MD, JD 909-558-2055 |
|Contact: Lyn M Edgemon 909-558-2055 email@example.com |
|Principal Investigator: Abel Torres, MD, JD |
Loma Linda University
||Abel Torres, MD
||Professor and Chairman, Department of Dermatology
No publications provided
||Loma Linda University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 14, 2012
||April 17, 2012
||United States: Food and Drug Administration
Keywords provided by Loma Linda University:
Basal Cell Carcinoma
Treatment of Skin Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell