A Study of OMX-0407 in Patients With Previously Treated Solid Tumours That Can't be Removed Surgically

Exclusion criteria

• . Untreated CNS metastases. Subjects with CNS metastases that have completed treatment at least two weeks previously and have either an unchanging or no neurological deficit whilst not receiving corticosteroid therapy are eligible. Subjects with known CNS metastases must have received CNS directed therapy and not systemic therapy alone to be eligible for the study.
• . Either Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 2.5 upper limit of normal (ULN) unless in the presence of hepatic metastases when AST or ALT as high as 5 ULN is acceptable. Serum bilirubin \> 1.5 ULN unless in the presence of hepatic metastases when serum bilirubin as high as 3 x ULN is acceptable. Subjects with isolated increases in alkaline phosphatase (ALK) are eligible for the study.
• . Prothrombin Time or equivalent such as international normalized ratio (INR) or the Quick test \> 1.5 ULN.
• . Activated Partial Thromboplastin Time (PTT) \> 1.5 ULN.
• . Chronic anticoagulant therapy that cannot be discontinued for tumour biopsy if necessary.
• . Previous biological or unlicensed anticancer therapy within five half-lives or thirty days of treatment - whichever is shortest.
• . Prior cytotoxic chemotherapy in the preceding three weeks.
• . Persistent fever or other signs of uncontrolled infection.