Phase I Study of CBP501 and Cisplatin in Patients With Advanced Refractory Solid Tumors

Inclusion Criteria

• •Signed informed consent obtained prior to initiation of any study-specific procedures.
• •Pathologically-confirmed, locally advanced or metastatic solid tumors, refractory to standard therapy.
• •Male or female patients aged 18 years or over.
• •ECOG Performance Status (PS): 0-1.
• •Life expectancy \> 3 months.
• •Previous anticancer treatment must be discontinued at least 3 weeks prior to first dose of study treatment (6 weeks for mitomycin C; 6 weeks for anti-androgen therapy if discontinued prior to treatment initiation, with the exception of 8 weeks for bicalutamide).
• •Adequate organ function including the following:
• •Bone Marrow: absolute neutrophil count (ANC) ³ 1.5 x 109/L, platelet count ³ 100 x 109/L, hemoglobin ³ 9 g/dL
• •Hepatic: Bilirubin £ 1.5 x the upper limit of normal (ULN), aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) £ 2.5 x ULN (or ≤ 5 x ULN if liver metastases are present), INR £ 1.5 x ULN
• •Renal: Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ³ 70 mL/min (calculated according to the Cockroft and Gault formula)
• •Metabolic: serum potassium, calcium and magnesium ³ lower limit of normal (LLN)
• •Creatine phosphokinase isoenzymes: CPK-MB, CPK-MM ≤ ULN
• •Troponin I serum level within normal values
• •Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the investigator for 4 weeks prior to the study and 4 months after the last dose of study drug. For the purposes of this study, child-bearing potential is defined as: "All female patients unless they are post-menopausal for at least one year or are surgically sterile".
• •Male patients must use a form of barrier contraception approved by the investigator during the study and for 4 months after the last dose of study drug.
• •Ability to co-operate with the treatment and follow-up.