Expired Study
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New York, New York 10010


Purpose:

The purpose of this study is to determine how well a daily dose of 150 mg of Erivedge (vismodegib) reduces Keratocystic odontogenic tumor (KCOT) size, and to evaluate the safety of this dose. Erivedge is FDA-approved for use in adults with a specific type of skin cancer. However, the drug is experimental for patients with KCOT.


Study summary:

This is a single-center, interventional, single-arm, open-label, two-cohort clinical trial. A total of 20 patients will be enrolled (10 with NBCCS-associated KCOT and 10 with sporadic KCOT) over a period of 2 years. This is a 3 year study where each patient will undergo up to 1 year of treatment and up to 2 years of post-treatment follow-up. All patients will be assessed for safety and efficacy of the study drug GDC-0449 (Vismodegib).


Criteria:

Inclusion Criteria: - Males and females, 18 years of age and above at the time the informed consent form is signed; - Able to understand and sign the Informed Consent Form and other necessary paperwork prior to initiation of study procedures; - Able to communicate with the investigator/study site personnel, understand and comply with the study requirements, and willing to return for specified visits at the appointed time; - Patients who have received prior treatment for their KCOT and with a diagnosis of recurrent (maxillary or mandibular) sporadic KCOT or NBCCS-associated KCOT (single or multiple); - Diagnosis of KCOT will be done by past pathology report or by biopsy at the study site, if applicable; - Willingness to consent to biopsy of the lesion, if needed; - Willingness to delay excision of the target tumor site, unless evidence of disease progression or lack of drug tolerability; - Willingness to donate blood for genetic testing; - For female patients of childbearing potential, agreement to use two acceptable methods of birth control, including one barrier method during the study and 7 months after discontinuation of study drug; - For males with female partners of childbearing potential, agreement to use a male condom (with spermicide) and to advise their female partners to use an acceptable method of birth control during the study and for 2 months after the discontinuation of the study drug; - Agreement not to donate blood/blood products during the study and for 7 months after the discontinuation of the study drug; - For males not to donate sperm products or semen during treatment and for 2 months after the discontinuation of the study drug; - Able and willing to swallow pill; - No malabsorption syndrome or other condition that would interfere with enteral absorption; - At least 4 weeks since last chemotherapy, investigational therapy, radiotherapy or major surgical procedure and recovered from the first study drug administration; - KCOT measures at least 1 cm in one dimension on pretreatment volumetric CT scan; - No clinically significant abnormalities with clinical laboratory assessments; Exclusion Criteria: - Concurrent anti-tumor therapy; - Completion of the most recent anti-tumor therapy (including Vismodegib) less than 4 weeks prior to the initiation of treatment (first study drug administration); - Uncontrolled medical illness; - Pregnancy or lactation; female patients who are planning to become pregnant for the duration of the study and 7 months post-treatment; - Inability or unwillingness to swallow capsules; - Any medical or psychological illness or condition preventing adequate consent; - History of significant atherosclerotic disease, including the following: - Coronary artery disease (i.e., myocardial infarction within the past year or unstable angina); - Documented carotid atheroma; - Known HIV infection; - Current alcohol abuse; - History of resistance to vismodegib (patients who previous received vismodegib for BCC and had no clinical response will be excluded).


NCT ID:

NCT02366312


Primary Contact:

Principal Investigator
Brian L Schmidt, DDS, MD, PhD
NYU College of Dentistry


Backup Contact:

N/A


Location Contact:

New York, New York 10010
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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