Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392171
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2006-10-24
Brief Title:
The Effects of Continuous 28-day 2828 Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day 528 Treatment P04601
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
The Temozolomide RESCUE Study A Phase II Trial of Continuous 2828 Dose-intense Temozolomide CDIT Chemotherapy After Progression on Conventional 528 Day Temozolomide in Patients With Recurrent Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2017-05
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:
The purpose of this non-randomized open-label multicenter Phase II 2-stage design RESCUE study is to test the hypothesis that continuous 28-day oral dosing 2828 with dose-intense temozolomide 50 mgm2 for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles 2 months of conventional 5-day 528 cycles of high-dose temozolomide 150-200 mgm2
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