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|NCT02254954 : Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed GBM.|
|Ages||Min: 18 Years Max: N/A|
- 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.
- 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
- 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.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02254954
| Link to official Clinicaltrials.gov listing