Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479076
Status:
COMPLETED
Last Update Posted:
2011-01-26
First Post:
2007-05-24
Brief Title:
A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Single Agent-combination Hybrid Phase I Open-label Dose-escalation Study of the Safety Tolerability and Pharmacokinetics of Intravenous AVE0005 VEGF TrapAdministered Every 2 Weeks in Combination With Oral S-1 in Patients With Advanced Solid Malignancies
Status:
COMPLETED
Status Verified Date:
2011-01
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 of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients
The secondary objectives of this study are to assess the safety profile of AVE0005 to determine the pharmacokinetics of AVE0005 to make a preliminary assessment of antitumor effects
The secondary objectives of this study are to assess the safety profile of AVE0005 to determine the pharmacokinetics of AVE0005 to make a preliminary assessment of antitumor effects
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