Phase I Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 Single Agent for Refractory Solid Tumors

Inclusion Criteria

• •Provision of informed consent
• •Male or female ≥18 years of age
• •Histologic or cytologic confirmed locally advanced or metastatic cancer that has no standard therapeutic alternatives.
• •ECOG Performance status 0-1
• •A minimum life expectancy of 12 weeks
• •Adequate bone marrow, hepatic and renal function as evidenced by
• •* Absolute neutrophil count (ANC) \> 1.5 x 109/L
• •* Platelet count \> 100 x 109/L
• •* Hemoglobin \> 9.0 g/dL
• •* Serum bilirubin \< 1.5 x ULN
• •* AST/ALT (SGOT/SGPT) \< or = 2.5 x ULN for the reference laboratory or \< 5 x ULN in the presence of liver metastases
• •* Serum creatinine \< or = 1.5 x ULN
• •* Follicle-Stimulating Hormone (FSH) within normal baseline levels
• •* Male patients should have a detectable level of testosterone
• •Female patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin β-hCG\]) within 1 week of starting the study.
• •All potentially fertile patients will agree to use an effective form of contraception during the study and for 90 days following the last dose of ME-143 (an effective form of contraception is defined as an oral contraceptive or a double barrier method).
• •At least 4 weeks must have elapsed prior to Day 1 Cycle 1 since prior chemotherapy (6 weeks for carmustine or mitomycin C), investigational drug or biologic therapy and any toxicity associated with these treatments has recovered to ≤ NCI-CTCAE Grade 1.
• •At least 21 days must have elapsed prior to Day 1 Cycle 1, radiotherapy (limited palliative radiation is allowed \> 2 weeks), immunotherapy or following major surgery and any surgical incision should be completely healed