Clinical Trial Opportunity

We are pleased to let you know that the Stanford Dermatology Department and Comprehensive Cancer Center are taking part in an industry-sponsored national study evaluating the efficacy and safety of an oral, small molecule antagonist of the Hedgehog pathway (Hh) in patients with locally advanced and unresectable basal cell carcinoma.

Approximately 50 subjects will be enrolled at sites in the United States.

We would like to request your assistance in identifying patients who may be eligible for participation in the study. The inclusion/ exclusion criteria are listed at the end of this letter.
If you have any patients meeting the criteria and who may be interested in participating in the research study, please contact Tony Oro, MD at (650) 723-7843, oro@cmgm.stanford.edu or Anne Chang, MD, the Co-Principal Investigator at (650) 721-2699, alschang@stanford.edu.

We appreciate your assistance and look forward to collaborating with you to offer this research study to your patients.

Anthony Oro, MD, PhD Anne Chang, MD
Associate Professor of Dermatology Instructor, Director of Dermatological
Department of Dermatology Clinical Trials, Dept. of Dermatology
Stanford School of Medicine Stanford School of Medicine


Primary Outcome Measures:
The primary objective of this study is to estimate the clinical benefit of an oral, small molecule antagonist of the Hedgehog pathway (Hh) given as therapy for patients with locally advanced or metastatic BCC, as measured by overall response rate (ORR).

Selected Inclusion Criteria:
• Men and women age ≥ 18 years
• For patients with locally advanced BCC, histologically confirmed disease that is considered to be inoperable or medical contraindication to surgery (see below), in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, or plastic surgeon
• For patients with locally advanced BCC, radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate (e.g., hypersensitivity to radiation due to genetic syndrome such as Gorlin syndrome, limitations because of location of tumor, or cumulative prior radiotherapy dose). For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
• Patients with nevoid BCC syndrome (Gorlin syndrome) may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above.

Selected Exclusion Criteria:
• Pregnancy or lactation
• Life expectancy of < 12 weeks
• Concurrent non–protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy)
• History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix
• Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics