COAST Therapy in Advanced Solid Tumors and Prostate Cancer

Inclusion Criteria18

• Patient must have advanced solid tumor cancer of any type (Phase I) or advanced prostate cancer (Phase II). Prostate cancer patients must have a PSA of at least 0.1 ng/mL.
• Tissue diagnosis documented by pathology report, or clinic note attesting to same.
• Measurable / evaluable tumor by RECIST, quantitative blood biomarker, or radionuclide imaging
• Voluntary, signed and dated, Institutional Review Board (IRB) approved consent form in accordance with regulatory and institutional guidelines.
• Documented progression of disease during treatment with one or more standard systemic regimens. Single or multiple regimens of chemotherapy, hormone suppression therapy, radiation therapy, surgery, immunotherapy, or adoptive cell therapy are allowed.
• years of age or older.
• ECOG performance status of 0-2.
• Bilirubin ≤ 1.5 times upper limit of normal (ULN) and AST / ALT ≤ 3 times ULN. Subjects with Gilbert's syndrome may be included if the total bilirubin is \< 3 times ULN and the direct bilirubin is within normal limits.
• Serum creatinine ≤ 1.5 times ULN.
• Absolute neutrophil count (ANC) ≥ 1,000 cells / mm3
• Platelet count ≥ 75,000 cells / mm3
• Hemoglobin ≥ 9 g/ dL.
• Fasting glucose ≤ 160 mg/dL or non-fasting glucose ≤ 200 mg/dL.
• Urinalysis with no clinically significant abnormalities.
• Adequately controlled blood pressure as determined by the treating investigator.
• Subjects with the potential to produce children must agree to effective contraceptive method use during study participation.
• Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks prior to study entry.
• Patients being considered for a dose level containing nelfinavir mesylate must discontinue any statin use within 48 hours of beginning study treatment.