Safety Study of PRLX 93936 in Patients With Advanced Solid Tumors

Inclusion Criteria

• •Histologically confirmed solid tumors
• •Tumor progression after receiving standard/approved chemotherapy and for whom no available treatment provides clinical benefit
• •One or more metastatic tumors measurable on a CT scan or MRI per RECIST criteria
• •ECOG performance 0-1
• •Life expectancy of at least 3 months
• •Age \>/= 18 years
• •A negative pregnancy test (if female of child-bearing potential)
• •Acceptable liver function:
• •Bilirubin \</= 1.5 times the Upper Limit of Normal (ULN)
• •AST (SGOT), ALT (SGPT) and Alkaline phosphatase \</= 2.5 times ULN (if liver metastases are present, then \</= 5 times ULN is allowed)
• •Acceptable renal function:
• •Serum creatinine within normal limits, OR calculated creatinine clearance \>/= 60 mL/min/1.73m2 for patients with creatinine levels above institutional normal
• •Acceptable hematologic status:
• •Granulocyte count \>/= 1500 cells/mm3
• •Platelet count \>/= 100,000 (plt/mm3)
• •Hemoglobin \>/= 9.0 g/dL
• •Urinalysis: no clinically significant abnormalities
• •Acceptable coagulation status:
• •PT within normal limits
• •aPTT within normal limits
• •Completed any chemotherapy, major surgery, or irradiation at least four weeks before enrollment in this study (six weeks for mitomycin-C or nitrosoureas, and two weeks for "targeted" therapies such as kinase inhibitors). Patient must have recovered from all toxicities incurred as a result of previous therapy.
• •QT intervals of QTC \</= 450 msec for men and \</= 470 msec for women (as measured by Hodges equation)
• •Left ventricular ejection fraction \>/= 50% by 2D Echocardiogram (or \> institutional lower limits of normal)