Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: EPO EPO906 Brain metastasis Lung cancer Lung metastasis NSCLC
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 89
Healthy volunteers: no

Brief summary:
The study objective is to evaluate the maximum tolerated dose, safety and efficacy of patupilone in patients with NSCLC who have progressed after prior chemotherapy.

Detailed description:

Arms:

Interventions: intervention 1: Patupilone
Intervention descriptions: intervention 1: 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.

Protocol document: