Vismodegib for Treatment of Basal Cell Carcinoma

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abel Torres, MD

Criteria

Inclusion Criteria:

1. Willing and able to give informed consent.

2. At least 18 years of age.

3. Have a confirmed BCC at one of listed anatomical sites which must be biopsy-confirmed at the study site and meets this criteria:

• non-infected

• 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

4. Free of any significant physical abnormalities (e.g., tattoos) at treatment site.

5. 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

6. 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.

7. 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.

8. Agrees not to donate blood or blood products during the study and for 7 months after last dose.

Exclusion Criteria:

1. Prior treatment with GDC-0449 or any HH Pathway Inhibitor

2. 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.

3. Have any dermatological disease at treatment site that may be exacerbated by treatment with vismodegib or cause difficulty with examination (e.g., psoriasis, eczema).

4. Inability or unwillingness to swallow capsules

5. Pregnancy or lactation

6. Have a desire to conceive in the future.

7. Patients with known Gorlin's (basal cell nevus) syndrome or clinical suspicion of Gorlin's Syndrome)

8. Recent (i.e., within the past 28 days), current, or planned participation in another experimental drug study

9. Have active chemical dependency or alcoholism..

10. 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

11. 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.

12. Received any cancer chemotherapy within 6 months before study treatment initiation (subject must not currently have any evidence of cancer, other than skin cancer).

13. 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