Dose Escalating Study of the Safety and Efficacy of Patupilone, q3w, in Patients With Non-small Cell Lung Cancer

Patupilone (2.5 mg/mL) was supplied as a clear, colorless concentrate for solution for infusion in glass vials containing 5 mg/2 mL in Phase I and 10 mg/4 mL in Phase II part of the study. Patupilone was administered as a single intravenous (i.v.) infusion over 5 to 10 minutes (Amendment 1) till Amendment 2 and over 10 to 20 minutes (Amendment 2) till the completion of Phase I part of the study. Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks in Phase II part of the study.