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

• Conditions: WHO Grade IV recurrent intracranial malignant glioblastoma; MedDRA version: 6.1Level: PTClassification code 10018337

• Registration Number: EUCTR2005-004627-18-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-05
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 397

Inclusion Criteria

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. 2 Patients must have evidence of tumor progression following radiation and chemotherapy as measured by an MRI. 3 Patients may have undergone prior surgical resection and will be eligible 4 Patients must have adequate organ function 5 Patients must have a KPS of 70 or higher
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

1 Have a second primary malignancy except adequately treated basal cell carcinoma of the skin . 2 Inability to comply with protocol or study procedures for example, an inability to swallow tablets . 3 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. 4 For patients receiving EIAEDs Patients must discontinue EIAEDs 8805;14 days prior to study enrollment The investigator may prescribe non-EIAEDs refer to Attachment JCBF.5 . 5 Concurrent administration of any other systemic anticancer therapy. 6 Have received prior therapy with enzastaurin. Have received any prior nitrosourea including lomustine therapy. Have received prior therapy with bevacizumab Avastin . 7 Have received treatment with either stereotactic radiosurgery or intratumoral chemotherapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified