Clinical Trial Details
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NCT02254954 : Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed GBM.
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Subjects at least 18 years of age

- Histologically proven supratentorial GBM or gliosarcoma

- Use of effective contraception by women of childbearing potental.

- Use of effective contraception by fertile males with a female partner of childbearing

- Interval of at least 3 weeks after biopsy or open surgery and able to begin study

- Result from a post-operative contrast-enhanced brain MRI within 72 hours after
surgery or biopsy.

- Adequate bone marrow function

- Karnofsky Performance Score of at least 70.

Exclusion Criteria:

- Prior treatment for glioblastoma or gliosarcoma.

- Evidence of leptomeningeal spread of glibolastoma or gliosarcoma.

- Tumor foci below the tentorium or beyond the cranial vault.

- Evidence of recent hemorrhage on post-operative contrast enhanced brain MRI (except
hemosiderin, resolving hemorrhage changes related to surgery, presence of punctuate
hemorrhage in tumor).

• Aspartate aminotransferase or alanine aminotransferase > 3 times the upper limit of

- Supine systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg.

- Medical history of orthostatic hypotension.

- International normalized ratio > 1.5 on anticoagulant therapy, active bleeding on low
molecular weight heparin, or chronic condition with a high risk of bleeding.

- Severe renal impairment.

- Severe hepatic impairment.

- Severe, active co-morbidity: (e.g. cardiac disease; respiratory disease; chronic
hepatitis; hemtological and bone marrow diseases; severe malabsoprtion; human
immunodeficiency virus).

- No concurrent strong CYP3A4 inducers or inhibitors.

- No investigational drug within 4 weeks of starting study treatment.

- Any life-threatening condition that could affect protocol compliance.
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