A Phase I, Multi-Center, Open-Label, Treatment Duration Increment, Expansion, Safety, and Pharmacodynamic Study of CX-4945 Administered Orally Twice Daily to Patients with Advanced Basal Cell Carcinoma (CX-4945-07)

The purpose of this study is to test a new investigational drug (one that is not approved by the US Food and Drug Administration) called CX-4945. Previous studies have shown that one key step in developing BCC is a pathway called the “hedgehog pathway” (HH). CX-4945 interrupts this pathway, and the tumor may be controlled. This study is being conducted to determine the best dose of CX-4945 recommended for the phase II study, and the best schedule of administration of CX-4945, when given by mouth two times a day for 28 consecutive days, in a 4-week (28 days) cycle.

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

A department of Inova Fairfax Hospital

• For patients with locally advanced BCC, histologically confirmed disease with at least one lesion that was 10 mm or more in at least 1 dimension by color photograph that is considered to be inoperable for medical surgery in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, or plastic surgeon
• Patients with nevoid BCC syndrome (Gorlin syndrome) may enroll in this study but must meet the criteria for locally advanced or metastatic disease
• Additional eligibility in protocol

• Pregnancy
• Tumor histology consistent with basosquamous carcinoma (basal cell carcinoma with squamous differentiation or metatypical carcinoma)
• 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
• Difficulty with swallowing oral medications
• Active or uncontrolled infections or with serious illnesses or medical conditions
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk from treatment complications
• Chronic diarrhea (excess of 2-3 stools/day above normal frequency)
• Additional ineligibility in protocol

For more information, go to: https://clinicaltrials.gov/ct2/show/NCT03897036