Inclusion Criteria

Inclusion Criteria

- Patients at least 18 years of age

- Histologically confirmed glioblastoma multiforme or gliosarcoma

- Recurrent disease with an interval of at least 3 months following initial
radiotherapy and temozolomide

- Interval of at least 3 weeks between end of surgery for recurrent disease and start
of protocol (if applicable)

- KPS 60% or higher

- Adequate bone marrow function

Exclusion Criteria

- Histology other than astrocytoma grade IV or gliosarcoma

- Tumor foci below the tentorium or cranial vault

- Glioblastoma or gliosarcoma disease with leptomeningeal spread

- Elevated serum aspartate aminotransferase, alanine aminotransferase, or bilirubin

- Moderate to severe hepatic impairment

- Confirmed systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg

- History of orthostatic hypotension

- Renal insufficiency

- Prior chemotherapy for recurrent glioblastoma with nitrosourea compounds or
bevacizumab

- Prior focal radiotherapy

- Severe, active co-morbidity (e.g. cardiac disease; respiratory disease; chronic
hepatitis; hematological and bone marrow diseases; severe malabsorption)

- No other active cancer

- No concurrent cytochrome P450 3A4 inducers

- No concurrent strong cytochrome P450 3A4 inhibitors

- No other concurrent investigational agents