Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290771
Status:
TERMINATED
Last Update Posted:
2011-05-16
First Post:
2006-02-10
Brief Title:
Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea HU in Patients With Recurrent Glioblastoma Multiforme GBM
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Phase II Open-label Multicenter Study Evaluating the Efficacy of Imatinib Plus Hydroxyurea HU in Patients With Progressive Glioblastoma Multiforme GBM Receiving or Not Receiving Enzyme-inducing Anticonvulsant Drugs EIACDs
Status:
TERMINATED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was an investigational study to assess the objective overall response OOR rate complete response CR partial response PR of imatinib mesylate and hydroxyurea hydroxycarbamide combination therapy in patients with recurrent glioblastoma multiforme brain tumors This study also evaluated the duration of tumor response as per MacDonald criteria clinical benefit progression-free survival rate at 6 and 12 months and the survival rate at 12 and 24 months
Detailed Description:
This ClinicalTrialsgov record includes the results from two studies Novartis protocol IDs CSTI571H2201 and CSTI571H2202 which were conducted separately but reported together in a single clinical study report Both studies were phase II open-label multicenter single-arm studies that evaluated the efficacy of imatinib mesylate plus hydroxyurea in subjects with progressive glioblastoma multiforme The studies were identical in design with two exceptions Patients in study CSTI571H2201 received a dose of imatinib 600 mg once daily and were not allowed concomitant use of enzyme-inducing anticonvulsant drugs EIACDs patients in study CSTI571H2202 received a dose of imatinib 500 mg twice daily and were allowed concomitant use of EIACDs
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 |
|---|---|---|---|
| CSTI571H2202 | OTHER | Novartis Pharmaceuticals | None |