Clinical Trial Details
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NCT01499251 : Macitentan in Combo With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma
PhasePhase 1
AgesMin: 18 Years Max: N/A
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
(unless there is medical justification for bilirubin elevation, and aspartate
aminotransferase, alanine aminotransferase, and alkaline phosphatase are normal)

- Moderate to severe hepatic impairment

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

- History of orthostatic hypotension

- Renal insufficiency or serum creatinine above the normal reference range

- Prior chemotherapy for recurrent glioblastoma with nitrosourea compounds or

- 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
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