Ignite Creation Date:
2024-05-05 @ 9:50 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00977431
Status:
COMPLETED
Last Update Posted:
2019-02-18
First Post:
2009-09-14
Brief Title:
Open Label Trial to Explore Safety of Combining Afatinib BIBW 2992 and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Phase I Open Label Trial to Explore Safety of Combining BIBW 2992 and Radiotherapy With or Without Temozolomide in Newly Diagnosed GBM
Status:
COMPLETED
Status Verified Date:
2019-02
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 study is a phase I open label trial to determine the Maximum Tolerated Dose MTD safety pharmacokinetics and efficacy of BIBW 2992 an epidermal growth factor receptorEGFRinhibitor to be used in combination with
radiotherapy alone in patients with an unmethylated functioning MGMT gene regulator or
radiotherapy and Temozolomide in patients with a methylated silenced O6-methylguanine-DNA methyltransferase gene MGMT to treat newly diagnosed patients with Grade IV Glioblastoma primary brain cancer
radiotherapy alone in patients with an unmethylated functioning MGMT gene regulator or
radiotherapy and Temozolomide in patients with a methylated silenced O6-methylguanine-DNA methyltransferase gene MGMT to treat newly diagnosed patients with Grade IV Glioblastoma primary brain cancer
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 |
|---|---|---|---|
| 2008-007284-17 | EUDRACT_NUMBER | None | None |