A Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors

Inclusion Criteria: * Males / females, ≥ 18 years old, any race / ethnicity, who can provide written Informed Consent * Life expectancy ≥ 3 months * Pathologically confirmed solid tumor, locally advanced / metastatic, refractory after standard therapy, or for which no effective curative or surgical treatment options are available * Measurable disease on baseline imaging per RECIST 1.1 criteria * ECOG performance status ≤ 1 * Liver function: * Bilirubin ≤ 1.5 X upper limit of normal * AST, SGOT, ALT, SGPT ≤ 2.5 X upper limit of normal, \< 5 upper limit if there are liver metastases * Renal function: * Serum creatinine within normal limits * Hematologic status: * Absolute neutrophil count ≥ 1500 cells/mm3. * Platelet count ≥ 100,000/mm3. * Hemoglobin ≥ 9 g/dL * Coagulation status: * Coagulation Prothrombin time ≤ 1.5 X upper limit * Partial thromboplastin time ≤ 1.5 X upper limit * Males must agree to use condoms during sex to prevent spillage of semen for the duration of the study and for 3 months after the patient leaves the study * Females in the study must not be pregnant or breast feeding and not planning to become pregnant or breast feed for the duration of the study, and for at least three months after study completion * Women of childbearing potential must commit to using a double barrier method of contraception, an intrauterine device, or sexual abstinence for the duration of the study and for at least three months after study completion * Serum pregnancy test for wom…