Status:
TERMINATED
Clinical Study on Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma
Lead Sponsor:
Actelion
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a prospective, single-center, open-label, 3+3 dose escalation Phase 1 safety study. Adults with newly diagnosed GBM or gliosarcoma will receive macitentan in addition to the standard of care t...
Eligibility Criteria
Inclusion
- 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 potential.
- Interval of at least 3 weeks after biopsy or open surgery and able to begin study treatment.
- 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
- 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 normal.
- 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.
Key Trial Info
Start Date :
January 8 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02254954
Start Date
January 8 2015
End Date
September 29 2016
Last Update
February 27 2018
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030