Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361842
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2006-08-07
Brief Title:
Multicenter Study Of CPX-1 Irinotecan HCl Floxuridine Liposome Injection In Patients With Advanced Colorectal Cancer
Sponsor:
Jazz Pharmaceuticals
Organization:
Jazz Pharmaceuticals
Study Overview
Official Title:
Multicenter Open-Label Phase 2 Study Of CPX-1 Irinotecan HCl Floxuridine Liposome Injection In Patients With Advanced Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2021-07
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 purpose of this study is to determine whether CPX-1 is effective in patients with advanced colorectal cancer who have already received chemotherapy that included the drug oxaliplatin or irinotecan All patients will receive CPX-1 at a dose of 210 unitsm2 over 90 minutes every two weeks
Detailed Description:
CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine The two drugs are present inside the liposome in a fixed 11 molar ratio CPX-1 was developed as a means of delivering and preserving a fixed 11 molar ratio of the two drugs This ratio was found in vitro and in vivo models of cancer to have synergistic anti-cancer activity and preservation and delivery of this ratio is important because other ratios of these two drugs have been found to be antagonistic or only additive Both floxuridine and irinotecan HCl are active chemotherapeutic agents each approved for clinical use in the United States and Canada for colorectal cancer Current practice routinely administers 5- fluorouracil with irinotecan in combination regimens in first or second line treatment without the means of preserving the synergistic ratio
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