Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 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 (Appendix A)
• •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) \< 2.5 x ULN for the reference laboratory or \< 5 x ULN in the presence of liver metastases
• •* Serum creatinine \< 1.5 x ULN
• •Adequate cardiac function as evidenced by:
• •* CK-MB within normal levels at baseline
• •* Troponin T within normal levels at baseline
• •* The average QTc from triplicate screening ECGs (every 5 minutes over a total of 15 minutes) must be \< 470 msec to be eligible for the study. (If a patient has an average QTc interval \>470 msec at screening, the screening ECG may be repeated twice (at least 24 hours apart).
• •* LV Ejection Fraction \> lower limit of institutional normal level
• •All potentially fertile patients will agree to use an effective form of contraception during the study and for 30 days following the last dose of ME-344 (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 nitrosourea 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, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for "limited palliative radiotherapy", defined as a course of therapy encompassing \<25% total bone marrow volume and not exceeding 30 Gy.