Overview

This trial is active, not recruiting.

Condition glioblastoma multiforme
Treatments enzastaurin, radiation
Phase phase 2
Sponsor Eli Lilly and Company
Start date October 2007
End date February 2010
Trial size 60 participants
Trial identifier NCT00509821, 11491, H6Q-MC-S039

Summary

The purpose of the protocol is to induce a novel radiochemotherapy with enzastaurin as first-line treatment regimen in glioblastoma: Patients with active, unmethylated MGMT promoter will be treated with enzastaurin before, concomitant, and after radiotherapy to determine safety and PFS at 6 months (PFS-6) in phase II.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Enzastaurin before and concomitant with radiotherapy followed by Enzastaurin maintenance therapy
enzastaurin LY317615
Safety Run in Regimen 1: 1125 mg loading dose D(-)7 then 500 mg QD, oral, daily until disease progression Regimen 2: 1125 mg loading dose D(-)7 then 250 mg BID, oral, daily until disease progression
radiation
Involved-field radiotherapy will be administered D1 after 7 day lead in enzastaurin treatment at a dose of 54 to 60 Gy, given in individual doses of 1.8 to 2 Gy 5 days a week for 6 weeks

Primary Outcomes

Measure
Progression free survival rate 6 months after surgery.
time frame: After 6 months

Secondary Outcomes

Measure
Survival rate at 1 and 2 years after surgery
time frame: 1 and 2 year
Response rate
time frame: baseline to progressive disease

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Present with newly diagnosed histologically proven supratentorial GBM. - Demonstration of an unmethylated MGMT-promotor - Patients must sign an informed consent document. Patients must be at least 18 years of age. - Estimated life expectancy of at least 12 weeks - Tumor tissue specimens (paraffin-embedded and/or frozen) from the GBM surgery or biopsy must be available for central pathology review and exploratory analysis of PKC-beta targets (for example, GSK3beta). - Disease evaluated by Gd-MRI (magnetic resonance imaging) within 72 hours postoperatively - Interval of greater than or equal to 2 and less than or equal to 4 weeks since surgery or biopsy - ECOG Performance Status of less than or equal to 2 - Adequate organ function including the following: - adequate bone marrow reserve: white blood cell (WBC) count greater than or equal to 3.0 X 109/L, absolute neutrophil count (ANC) greater than or equal to 1.5 X 109/L, platelet count greater than or equal to 75.0 X 109/L, and hemoglobin greater than or equal to 10.0 g/dL (greater than or equal to 6.2 mmol/L). - Hepatic: bilirubin less than or equal to 1.5 times the upper limit of normal (X ULN), alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) less than or equal to 2.5 X ULN, or less than or equal to 5 X ULN with liver metastases - Renal: serum creatinine less than or equal to 1.5 X ULN - Blood clotting: prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits - Patients must discontinue use of enzyme-inducing antiepileptic drugs (EIAEDs) greater than or equal to 14 days prior to study enrollment. The investigator may prescribe non-EIAEDs. Patients who must begin EIAED therapy while on study will be allowed to remain on study. - Clinically normal cardiac function without history of ischemic heart disease in the past 6 months and normal 12-lead electrocardiogram (ECG); no history of stroke Exclusion Criteria: - Have a prior malignancy (other than glioblastoma, or adequately treated carcinoma in situ of the cervix, or nonmelanoma skin cancer), unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence - Unable to undergo Gd MRI - Prior chemotherapy within the last 5 years - Prior chemotherapy for a brain tumor - Prior radiotherapy of the head - Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin - History of coagulation disorder associated with bleeding, or recurrent thrombotic events - Are receiving concurrent administration of anticoagulant therapy - Placement of Gliadel® wafer at surgery - Have a serious concomitant systemic disorder (for example, active infection including HIV, or cardiac disease) - patients who are pregnant, anticipate becoming pregnant within 6 months after study participation, or are currently breast-feeding - 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

Additional Information

Official title Enzastaurin Before and Concomitant With Radiation Therapy, Followed by Enzastaurin Maintenance Therapy in Patients With Newly Diagnosed Glioblastoma Without Methylation of the Promoter Gene of MGMT Enzyme - a Phase II Study
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.