Ignite Creation Date:
2024-05-05 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00558922
Status:
TERMINATED
Last Update Posted:
2009-07-30
First Post:
2007-11-13
Brief Title:
A Phase 1-2 XIAP Antisense AEG35156 With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Aegera Therapeutics
Organization:
Aegera Therapeutics
Study Overview
Official Title:
A Phase 1-2 Multicenter Open-Label Study of the X-Linked Inhibitor of Apoptosis XIAP Antisense AEG35156 Given in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unacceptable Neurotoxicity 2 cases
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multicenter phase 1-2 study Following determination of the recommended AEG35156 dose in combination with carboplatin and paclitaxel in the initial Phase 1 part of this study additional patients will be enrolled in the Phase 2 part of the study to assess the activity of the combination in advanced non small cell lung cancer
Detailed Description:
Apoptotic induction in cancer cells is a sought after therapeutic goal Most successful anticancer agents activate apoptosis pathways in the cancers they treat Apoptotic pathways in cells appear to converge on a single family of enzymes the caspases which are proteases that dismantle the cell in an orderly non-inflammatory fashion resulting in cell death The X-linked Inhibitor of Apoptosis XIAP is the only known cellular inhibitor of caspases its over expression thereby blocking the principal means of apoptosis A wide range of evidence indicates that cellular overexpression of members of the IAP family is a fundamental means by which many cancer cells evade death even in the presence of strong extrinsic death receptor-mediated and intrinsic mitochondria-mediated apoptotic cues The inhibition of cellular XIAP activity specifically in cancer cells under stress and primed for apoptosis by chemotherapeutic agents is viewed as a powerful means of tipping the balance towards cell death In particular XIAP down regulation has been shown to enhance taxane cytotoxicity preclinically AEG35156 is a second generation antisense which targets XIAP mRNA to lower XIAP levels and the apoptotic threshold of cancer cells enhancing their sensitivity to intrinsic death and chemotherapy AEG35156 may thus enhance the anticancer activity of carboplatin and paclitaxel in patients with advanced non small cell lung cancer
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