Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385775
Status:
TERMINATED
Last Update Posted:
2008-08-21
First Post:
2006-10-06
Brief Title:
Study of XIAP Antisense for Advanced Cancers
Sponsor:
Aegera Therapeutics
Organization:
Aegera Therapeutics
Study Overview
Official Title:
A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Dosing cohort 650mg exceeded current 350mg dosing in other trials
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to find the maximum tolerated dose safety and toxicity profile and to identify any dose limiting toxicities of AEG35156 administered in 2-hour infusions to patients with advanced cancers
Detailed Description:
This is a Phase I study single-arm open-label dose escalation study to establish the recommended dose and activity of AEG35156 administered as a 2-hour daily infusion over 3 days initially followed by weekly 2-hour intravenous infusions in patients with advanced cancers Subjects eligible for study entry must have proven advanced or metastatic cancer refactory to conventional treatment or for which no conventional therapy exists The starting dose will be a fixed dose of 60 mgday with escalation by steps of 50 to 100 in successive cohorts Approximately of 30 patients will be entered in the study to determine the maximum tolerated dose
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