Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT01499251
Eligibility Criteria:
Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
* Moderate to severe hepatic impairment
* Confirmed systolic blood pressure \< 100 mmHg or diastolic blood pressure \< 50 mmHg
* History of orthostatic hypotension
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01499251
Study Brief:
Protocol Section:
NCT01499251