Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431561
Status:
COMPLETED
Last Update Posted:
2013-12-03
First Post:
2007-02-05
Brief Title:
Phase IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma
Sponsor:
Isarna Therapeutics GmbH
Organization:
Isarna Therapeutics GmbH
Study Overview
Official Title:
Multi-national Open-label Active-controlled Randomized Dose-finding Study to Evaluate Efficacy of 2 Doses of AP 12009 in Recurrent Glioma Administered Intratumorally as Continuous High-flow Microperfusion Over 7 Days Every Other Week
Status:
COMPLETED
Status Verified Date:
2013-12
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:
In this multinational dose finding Phase IIb study the efficacy and safety of two doses of AP 12009 compared to standard chemotherapy temozolomide or PCV is investigated in adult patients with confirmed recurrent high-grade glioma
Detailed Description:
The purpose of this study is to compare the safety and efficacy of two doses of AP 12009 and standard chemotherapy in adult patients with recurrent high-grade glioma anaplastic astrocytoma AA WHO grade III or glioblastoma GBM WHO grade IV AP 12009 is a phosphorothioate antisense oligodeoxynucleotide specific for the mRNA of human transforming growth factor-beta2 TGF-beta2 The growth factor TGF-beta plays a key role in malignant progression of various tumors by inducing proliferation invasion metastasis angiogenesis and escape from immunosurveillance It has been shown that in a number of tumor types the degree of TGF-beta production strongly correlates with tumor grade and stage In patients with high-grade glioma the TGF-beta2 overexpression is associated with disease stage clinical prognosis and the immunodeficient state of the patients
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