Safety Study of MBP-426 (Liposomal Oxaliplatin Suspension for Injection) to Treat Advanced or Metastatic Solid Tumors

Inclusion Criteria

• •Pathologically-confirmed malignancy that is locally advanced or metastatic solid tumor and is refractory to standard therapy or for which conventional therapy is not reliably effective or no effective therapy is available
• •18 years of age or older
• •ECOG Performance Status of 0, 1, or 2
• •Adequate clinical laboratory values:
• •* absolute neutrophil count greater than or equal to 1500 cells/microliter
• •* platelets greater than or equal to 100,000 cells/microliter
• •* serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) for the institution
• •* creatinine clearance (calculated) \> 60 mL/min (using the Cockcroft-Gault equation)
• •* bilirubin less than or equal to 1.5 x ULN
• •* alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 x ULN (patients with known liver metastases may have up to 5 times ULN AST and ALT levels).
• •Ability to cooperate with treatment and follow-up schedules
• •Negative pregnancy test and using at least one form of contraception as approved by the Investigator prior to study entry if a female patient of childbearing potential or a male patient with a female partner of childbearing potential
• •Measurable disease as defined by RECIST criteria or non-measurable disease
• •Patients with known brain metastases may be included as long as they have been clinically stable for one month or more, and are not receiving dexamethasone
• •Ability to maintain a central intravenous access (e.g. PICC, Groshong, or Hickman line)
• •Signed informed consent prior to the start of any study specific procedures