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Sponsored by: |
Eli Lilly and Company |
---|---|
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00509821 |
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.
Condition | Intervention | Phase |
---|---|---|
Glioblastoma Multiforme |
Drug: enzastaurin Radiation: radiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Enzastaurin before and concomitant with radiotherapy followed by Enzastaurin maintenance therapy
|
Drug: enzastaurin
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
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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
Germany | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Berlin, Germany, 13553 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Erlangen, Germany, 91054 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Frankfurt, Germany, D-60596 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Freiburg, Germany, 79106 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Hamburg, Germany, 22767 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Bochum, Germany | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Leipzig, Germany, 04103 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Mannheim, Germany, 68167 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Regensburg, Germany, 93053 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Ulm, Germany, 89081 | |
Contact: Eli Lilly | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Heidelberg, Germany, D-69120 | |
Contact: Eli Lilly |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 11491, H6Q-MC-S039 |
Study First Received: | July 30, 2007 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00509821 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |