An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics and Pharmacodynamics of Warfarin in Patients With Advanced Malignancies

Inclusion Criteria

Inclusion criteria

- Age ≥ 18 years of age

- Life expectancy ≥3 months

- Histologically documented advanced solid tumors which have progressed after standard
systemic therapy or for which standard systemic therapy does not exist

- Agents containing warfarin or heparin must be discontinued 7 days prior to enrollment
in the study

Exclusion criteria

- History of/or active bleeding disorders

- Known hypersensitivity to warfarin or related compounds

- The use of vitamin K

- Central lines that require anticoagulant maintenance

- The use of agents containing warfarin and heparin

- Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis Other
protocol-defined inclusion/exclusion criteria may apply