Glioblastoma Clinical Trial
Official title:
A Single-center, Open-label, Phase 1 Study of Macitentan, Radiotherapy and Temozolomide Concurrent Therapy Followed by Maintenance Therapy With Macitentan and Temozolomide in Subjects With Newly Diagnosed Glioblastoma
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.
n/a
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