Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407459
Status:
COMPLETED
Last Update Posted:
2011-09-02
First Post:
2006-12-04
Brief Title:
Phase II Study of Bevacizumab Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma
Sponsor:
Armando Santoro MD
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2011-08
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:
The primary objective is to assess antitumor activity of the combination of bevacizumab pemetrexed and carboplatin in terms of time to progression
Detailed Description:
Secondary endpoints are to evaluate
the objective response rate RR of the combination
the toxicity and the safety profile of the combination
the duration of response RD and time to treatment failure TTF
the overall survival OS
RR TTP and OS according to baseline plasma VEGF levels introduced with Amendment 1 dated 8112007
the objective response rate RR of the combination
the toxicity and the safety profile of the combination
the duration of response RD and time to treatment failure TTF
the overall survival OS
RR TTP and OS according to baseline plasma VEGF levels introduced with Amendment 1 dated 8112007
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 |
|---|---|---|---|
| EUDRACT 2006-004429-27 | None | None | None |