CompletedPhase 2

Open-label Trial of SUBA™-Itraconazole (SUBA-Cap) in Subjects With Basal Cell Carcinoma Nevus Syndrome (BCCNS)

United States38 participantsStarted 2015-08-07

Plain-language summary

The study will assess the safety and efficacy of SUBA-Cap in subjects with Basal Cell Carcinoma Nevus Syndrome.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

Response rate of BCC lesions

Timeframe: Up to 26 weeks

NCT IDNCT02354261

SponsorHedgePath Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03