Vismodegib for Treatment of Basal Cell Carcinoma

NCT01543581 | Completed Phase 2 Results DMC

• 1 other identifier: 5110325
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Basal Cell Carcinoma

Keywords

Basal Cell Carcinoma; Treatment of Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Mohs Micrographic Surgery (MMS)

  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.

  The Mohs surgical excision of the target tumor was performed within two weeks, after the last day of treatment.

Secondary Outcomes (1)

• Complete Response Rate

  12 to 14 weeks

Study Arms (2)

Vismodegib

ACTIVE COMPARATOR

Oral vismodegib, 150mg per day for 12 weeks.

Drug: Vismodegib

Inactive placebo

PLACEBO COMPARATOR

Those to whom the inactive placebo is given.

Drug: Placebo

Interventions

Vismodegib DRUG

Oral vismodegib, 150mg per day for 12 weeks.

Also known as: Erivedge

Vismodegib

Placebo DRUG

Inactive placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Abel Torres, MD: lead

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

HhAntag691

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Results Point of Contact

• Title: Dr. Abel Torres, PI
• Organization: Loma Linda University Health, Department of Dermatology

atorres@llu.edu

(909) 558-2055

Study Officials

• Abel Torres, MD

  Professor and Chairman, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Abel Torres, M.C.,J.D, Chairman and Professor of Dermatology

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: March 5, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 26, 2014
• Results First Posted: September 26, 2014

Record last verified: 2014-09