Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Actelion
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed glioblastoma multiforme or gliosarcoma
Recurrent disease with an:
* interval of at least 3 months following initial radiotherapy and temozolomide
* interval of at least 3 weeks between end of surgery for recurrent disease and start of protocol therapy for patients who have undergone surgery for recurrent disease
KPS 60% or higher
Adequate bone marrow function Women of childbearing potential must have a negative serum beta-HCG pregnancy test documented within 14 days prior to study initiation.
Women of childbearing potential must agree to use two reliable methods of contraception from screening and up to 30 days after discontinuation of study treatment.
Males not naturally or surgically sterile, who have a female partner of childbearing potential, must agree to use two reliable methods of contraception from screening and up to 30 days after discontinuation of study treatment.
You may not be if
Histology other than astrocytoma grade IV (GBM or gliosarcoma)
Tumor foci below the tentorium or or beyond the cranial vault
Glioblastoma or gliosarcoma disease with leptomeningeal spread
Patients with a history of any other cancer, unless in complete remission, and off all therapy for that disease for a minimum of 5 years
Elevated serum aspartate aminotransferase, alanine aminotransferase, or bilirubin (unless there is medical justification for bilirubin elevation, and aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase are normal)
Renal insufficiency or serum creatinine above the normal reference range
Prior chemotherapy for recurrent glioblastoma with nitrosourea compounds or bevacizumab
Prior focal radiotherapy
Severe, active co-morbidity (e.g. cardiac disease; respiratory disease; chronic hepatitis; hematological and bone marrow diseases; severe malabsorption)
No other active cancer
No concurrent cytochrome P450 3A4 inducers
No concurrent strong cytochrome P450 3A4 inhibitors
No other concurrent investigational agents
Clareo Health | Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma
