Gliblastoma
Conditions
Sponsors
Eli Lilly and Company limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Patients present with histologically confirmed diagnosis of intracranial GBM (WHO Grade IV) (including gliosarcomas). Patients may be entered based on local pathology from the original diagnostic tumor specimen (See Section 4.1.1). 2- Patients must have evidence of tumor progression following radiation and chemotherapy as measured by an MRI. ars of age. 3- Patients may have undergone prior surgical resection and will be eligible if the following conditions apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Have a second primary malignancy (except adequately treated basal cell carcinoma of the skin). Patients who had another malignancy in the past, but have been free of active disease for more than 2 years, are eligible. - Inability to comply with protocol or study procedures (for example, an inability to swallow tablets). - Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. - For patients receiving EIAEDs: Patients must discontinue EIAEDs =14 days prior to study enrollment. The investigator may prescribe non-EIAEDs - Concurrent administration of any anticoagulant therapy - Have received any prior nitrosourea (including lomustine) therapy. - Have received prior therapy with bevacizumab (Avastin). - Have received treatment with either stereotactic radiosurgery or intratumoral chemotherapy. - Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare enzastaurin versus lomustine in terms of PFS time in patients with recurrent, intracranial GBM (WHO Stage IV).;Secondary Objective: The secondary objectives of the study are: - to compare the following between the randomized treatment arms: - overall survival (OS) - objective tumor response (OR) and duration of objective tumor response (based upon MRI) - time to deterioration of patient-reported Functional Assessment of Cancer Therapy – Brain (FACT-Br) Trial Outcome Index (TOI) - dimensions of QoL using the FACT-Br - change from baseline on neurologic exam - the safety and adverse event profile (including Common Terminology Criteria for Adverse Events [CTCAE Version 3.0, NCI 2003] grades for laboratory and nonlaboratory adverse events) - to characterize the burden of GBM in terms of lost productivity and general health status - to characterize enzastaurin pharmacokinetics in patients randomized to the enzastaurin arm - to assess biomarkers relevant to enzastaurin and disease state, and their correlation to clinical outcome.;Primary end point(s): Progressive disease will be identified by either a radiologic assessment (MRI) or evidence of neurologic progression. A worsening of the radiologic assessment or neurologic examination findings will be presumed evidence of PD. The date on which a patient’s disease has progressed will be the earlier date derived from radiologic progression or neurologic progression. Progression-free survival will be defined as the time from the date of randomization to the first date of PD or death from any cause. For patients who receive subsequent therapy prior to PD, PFS will be censored at the date of most recent progression-free assessment prior to the start of new therapy. For patients not known to have died or have PD as of the data cutoff date, PFS will be censored at the date of the last progression-free assessment. | — |
Countries
Austria, Belgium, Germany, Italy, Spain, United Kingdom
Outcome results
None listed