Ignite Creation Date:
2024-05-05 @ 9:47 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00967330
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2009-06-16
Brief Title:
A Study of Avastin Bevacizumab and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 2 arm study will compare the effect of Avastin irinotecan versus temozolomide in combination with conventional involved field radiotherapy in patients with newly diagnosed glioblastoma and a non-methylated MGMT promoter Patients will be randomized 31 to receive Avastin 10mgkg iv every 2 weeks irinotecan 125mgm2 iv every 2 weeks or temozolomide 75mgm2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mgm2 po daily on days 1-5 of each 4 week cycle The anticipated time on study treatment is until disease progression and the target sample size is 100-500 individuals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-010390-21 | None | None | None |