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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 266

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

- 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.
Patients with a QTc prolongation >450/470 msec
(males/females) and patients who have a congenital long-QT-syndrome in their
own or family medical history should be excluded, at the investigator’s discretion.
The investigator should consider the life-threatening nature of GBD and the
overall potential risk and benefit to the patient.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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