Ignite Creation Date:
2024-05-05 @ 9:53 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00988897
Status:
WITHDRAWN
Last Update Posted:
2009-12-23
First Post:
2009-09-28
Brief Title:
Colorectal Cancer RECHALLENGE
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase II Study of Modified FOLFOX-6 Chemotherapy as First-line Treatment of Metastatic Colorectal Cancer in Patients Who Have Received Oxaliplatin-based Adjuvant Chemotherapy
Status:
WITHDRAWN
Status Verified Date:
2009-12
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:
Primary Objective
To demonstrate that re-challenge with an oxaliplatin based regimen modified FOLFOX-6 will provide a clinical disease control rate DCR of at least 20 at the end of the chemotherapy
Secondary Objective
To evaluate other measures of tumours responses and safety
To demonstrate that re-challenge with an oxaliplatin based regimen modified FOLFOX-6 will provide a clinical disease control rate DCR of at least 20 at the end of the chemotherapy
Secondary Objective
To evaluate other measures of tumours responses and safety
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