Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109226
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2005-04-26
Brief Title:
A Study to Evaluate Avastin in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Phase II Multicenter Double-Blind Randomized Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of rhuMAb VEGF Bevacizumab a Recombinant Humanized Monoclonal Antibody to Vascular Endothelial Growth Factor in Combination With 5-Fluorouracil and Leucovorin Chemotherapy in Subjects With Metastatic Colorectal Cancer Who Are Not Optimal Candidates for First Line CPT-11
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase II multicenter double-blind randomized active-controlled trial is designed to evaluate the efficacy and safety of rhuMAb VEGF Avastin when administered at a dose of 5 mgkg every 2 weeks in combination with 5 FU fluorouracilleucovorin versus 5 FUleucovorin alone in subjects with previously untreated metastatic colorectal cancer who are not optimal candidates to receive first-line CPT-11 irinotecan A total of 48 doses of rhuMAb VEGF may be administered during this study maximum of 96 weeks of therapy
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