Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072748
Status:
COMPLETED
Last Update Posted:
2009-08-21
First Post:
2003-11-10
Brief Title:
Study Evaluating EKB-569 in Advanced Colorectal Cancer
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-08
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 non-randomized open-label outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced colorectal cancer Patients must have been previously treated with a fluoropyrimidine 5-FU or capecitabine and either oxaliplatin or irinotecan given concurrently or as separate regimens
The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced colorectal cancer
Secondary objectives include
To further evaluate the safety of EKB-569
To explore additional clinical activity parameters
To explore subject survival
To evaluate the pharmacokinetics of EKB-569
To assess subject reported outcomes
EKB-569 will be administered orally as a single-agent Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment
The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced colorectal cancer
Secondary objectives include
To further evaluate the safety of EKB-569
To explore additional clinical activity parameters
To explore subject survival
To evaluate the pharmacokinetics of EKB-569
To assess subject reported outcomes
EKB-569 will be administered orally as a single-agent Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment
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