A Randomized Phase 3 Study of Enzastaurin versus Lomustine in the Treatment of Recurrent, Intracranial Glioblastoma Multiforme - N/A

Eli Lilly and Company limited0 个研究点目标入组 397 人开始时间: 2006年1月18日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•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

•- 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.

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