First-in-Man, Dose-escalation Trial of c-Met Kinase Inhibitor EMD 1204831 in Subjects With Advanced Solid Tumors

Inclusion Criteria

• •1. Histologically or cytologically confirmed solid tumor, either refractory standard therapy or for which no effective standard therapy is available
• •2. Measurable or evaluable disease, as defined by RECIST 1.0
• •3. Men or women aged ≥ 18 years
• •4. ECOG performance status of 0 to 2
• •5. Adequate hematological function: Hemoglobin ≥ 9.0 g/dL; Neutrophils \> 1.5 x 109/L; Platelets ≥ 100 x 109/L
• •6. Adequate liver function: Total bilirubin ≤ 1.5 x ULN; AST/ ALT ≤ 2.5 x ULN
• •7. For subjects with liver metastases: Total bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 5 ULN
• •8. Adequate renal function: Serum creatinine \< 1.5 x ULN, and/or Calculated creatinine clearance \> 60 mL/min
• •9. Resolution of all acute chemotherapy, radiotherapy or surgery-related AEs to Grade ≤1, except for alopecia
• •10. Recovery from any surgical intervention
• •11. Subjects enrolling after the MTD has been determined must present specific c-Met alterations (overexpression, amplification, mutation)