Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004200
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2000-01-21
Brief Title:
Prinomastat Plus Temozolomide Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase II Study of the Matrix Metalloprotease Inhibitor Prinomastat in Combination With Temozolomide Following Radiation Therapy in Patients Having Newly Diagnosed Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2012-08
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:
RATIONALE Prinomastat may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor Drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die
PURPOSE Randomized phase II trial to study the effectiveness of prinomastat plus temozolomide in treating patients who have newly diagnosed glioblastoma multiforme
PURPOSE Randomized phase II trial to study the effectiveness of prinomastat plus temozolomide in treating patients who have newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES I Compare the one year survival rate and progression free survival of patients with newly diagnosed glioblastoma multiforme treated with prinomastat AG3340 or placebo and temozolomide following radiotherapy II Compare the safety of these regimens in these patients III Compare the quality of life in these patients on these regimens
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients receive oral prinomastat or placebo twice daily in combination with oral temozolomide daily on days 1-5 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 100 patients will be accrued for this study
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients receive oral prinomastat or placebo twice daily in combination with oral temozolomide daily on days 1-5 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 100 patients will be accrued for this study
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 |
|---|---|---|---|
| MSKCC-99116 | None | None | None |
| CDR0000067443 | None | None | None |
| MCC-12151 | None | None | None |
| MDA-DM-99254 | None | None | None |