Study of Topical SOR007 Ointment for Cutaneous Metastases

Inclusion Criteria

• •1. Signed informed consent;
• •2. Male and female patients ≥ 18 years of age;
• •3. Malignancies resulting in cutaneous metastasis originating from: breast, lung, head and neck, pancreatic, urinary bladder, prostate, testicular, ovarian, uterine, cervical, gastric, adrenal, thyroid, parathyroid cancers, or other solid tumors;
• •4. Cutaneous metastases diagnosis confirmed prior to consent by preferred institutional methodology which may include, but is not limited to: biopsy; conventional radiography; imaging techniques to include bone scan (scintigraphy), computed tomography (CT), fluorodeoxyglucose-positron emission tomography (FDG-PET)/CT), magnetic resonance imaging (MRI), F-fluoromisonidazole-(F-FMISO) PET/CT, fluorothymidine-(FLT) PET/CT, fluoroestradiol-(FES) PET/CT, and PET/MRI;
• •5. ECOG Grade 0 - 2, with minimum life expectancy of at least 3 months;
• •6. At least one baseline eligible lesion. Per RECIST criteria (version 1.1), an eligible lesion at baseline is considered measurable when ≥ 10mm diameter in the longest diameter;
• •7. Willing to refrain from using lotions, creams, etc. during the treatment period;
• •8. Subjects with adequate organ and bone marrow function as defined below:
• •* ANC ≥ 1,500/µl
• •* Hemoglobin ≥ 9.5 grams/dL
• •* Platelets ≥ 75,000/µl
• •* AST (aspartate transaminase or SGOT)/ALT (alanine aminotransferase or SGPT) ≤ 3.0 x ULN and total bilirubin ≤ 2.0 x ULN with no evidence of cholestasis
• •* Creatinine ≤ 1.5x ULN;
• •9. Last dose of any systemic non-taxane cytotoxic chemotherapy completed at least one day prior to Day 1. Last dose of any systemic taxane cytotoxic chemotherapy completed at least 4 weeks prior to Day 1
• •10. Willing to use appropriate birth control for patients of child-bearing potential;
• •11. Abstinence from all manner of physical contact near the treatment area during and up to 2 weeks after the treatment phase.