Clinical Study on Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma

Stopped early · Phase 1

Conditions studied: Glioblastoma

In brief

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 treatment for GBM. The study consists of a screening period, a treatment period, and a 30-day safety follow up period. The treatment period includes 6 weeks of concurrent therapy (macitentan+RT+TMZ), 4 weeks of monotherapy (macitentan) and 12 cycles of maintenance therapy (macitentan+TMZ). The study will end when the last treated subject has completed study treatment and the 30-day safety follow-up period. The planned duration of the study is approximately 34-38 months depending on the number of dose levels and cohorts of subjects enrolled. Subject participation in the study will be for approximately 16 months.

Key facts

Study ID

NCT02254954

Run by

Actelion

People needed

30

Starts

2015-01-08

Expected to finish

2016-09-29

Last updated by the study team

2018-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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