Phase IIb Open-label Trial of SUBA™-Itraconazole in Subjects With Basal Cell Carcinoma Nevus Syndrome (BCCNS)
The study will assess the safety and efficacy of SUBA-Cap in subjects with Basal Cell Carcinoma Nevus Syndrome.
• ECOG performance status of 0 or 1
• Diagnosis of Basal Cell Carcinoma Nevus Syndrome (BCCNS)
• Histologic confirmation of BCC from at least one lesion
• History of surgical removal of at least ten (10) prior BCCs
• Measurable disease as defined, namely at least ten (10) measurable lesions such that the sum of the longest diameters of the measurable lesions is at least 40 mm.
• Has failed, refused, or is not eligible for standard of care therapy for BCC
• Willingness to abstain from the use of non-study treatments for BCC, including but not limited to topical medications, PDT, and/or irradiation therapy.
• At least four weeks from prior major surgery
• Women who are pre-menopausal or not surgically sterile must be willing to use an acceptable contraceptive method for the duration of the study and for 30 days following the last dose of study drug
• Sexually active men must be willing to use an acceptable contraceptive method for the duration of time on study and for 30 days following the last dose of study drug
• Clinical laboratory values within the following ranges:
‣ Negative serum pregnancy test
⁃ Adequate hematologic function (ANC ≥1.5 x 10\^9/L; platelet count ≥75x10\^9/L; hemoglobin ≥9g/dL (in the absence of red blood cell transfusions in the prior 14 days)
⁃ Prothrombin time (PT-INR) or activated partial thromboplastin time (APTT) \<1.5 times the upper limit of normal range, unless currently receiving anticoagulants
⁃ Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥60 mL/min
⁃ Total bilirubin ≤ 1.5x the upper limit of normal unless considered due to Gilbert syndrome in which case, ≤ 3x the upper limit of normal
⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ the upper limit of normal
• Willingness to undergo biopsies (BCC lesions and normal skin)
• Willingness to provide prior and study-related BCC biopsies for central review
• Willingness to participate in collection of pharmacokinetic samples
• Willingness to not donate blood, semen, or eggs for the duration of the study and for 3 months following discontinuation of SUBA-Cap
• Willingness to delay removal of otherwise surgically eligible BCC's