Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398086
Status:
COMPLETED
Last Update Posted:
2019-11-22
First Post:
2006-11-08
Brief Title:
Gemcitabine Plus Albumin-bound Paclitaxel In Patients With Advanced Metastatic Pancreatic Cancer
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase I Trial of Gemcitabine Gemzar Plus ABI-007 ABRAXANE In Patients With Advanced Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2019-11
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:
To determine the maximum tolerated dose and dose-limiting toxicity of Gemcitabine plus Albumin-bound paclitaxel ABI-007 in patients with advanced metastatic pancreatic cancer
Detailed Description:
Albumin-bound paclitaxel is a novel solvent-free albumin-bound 130 nanometer particle form of paclitaxel designed to avoid the problems associated with solvents used in TaxolAbraxane prescribing information 2005 Albumin has a number of properties that make it an attractive molecule to combine with paclitaxel Albumin is a natural transporter of endogenous hydrophobic molecules such as water-insoluble vitamins and hormones Vorum 1999and albumin binding to the gp-60 receptor albondin initiates the caveolae-mediated endothelial transport of protein-bound and unbound plasma constituents John et al 2003 Minshall et al 2003 Tiruppathi et al 1997
This study consisted of a Phase 1 dose escalation phase a Phase 2 treatment phase and a 24-month follow-up phase
This study consisted of a Phase 1 dose escalation phase a Phase 2 treatment phase and a 24-month follow-up phase
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