Status:
COMPLETED
Phase IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma
Lead Sponsor:
Isarna Therapeutics GmbH
Conditions:
Glioblastoma
Anaplastic Astrocytoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 confi...
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 \[AA\], WH...
Eligibility Criteria
Inclusion
- Histopathologically confirmed diagnosis of recurrent or refractory high-grade glioma (anaplastic astrocytoma, WHO grade III; or glioblastoma, WHO grade IV)
- Supratentorial localization
- No more than two chemotherapy regimens including radiochemotherapy since primary diagnosis
- Eligible for either TMZ or PCV treatment
- Recovery from acute toxicity caused by any previous therapy
- Adequate organ functions
- KPS at least 70%
Exclusion
- Tumor surgery within 2 weeks prior to study entry
- Radiation therapy within 8 weeks prior to study entry
- Chemotherapy within 4 weeks prior to study entry (nitrosureas: 6 weeks)
- No more than 3 mg/day dexamethasone (or equivalent) at baseline
- Prior TGF-beta targeted therapy or tumor vaccination
- Baseline MRI shows mass effect
- Known active infection with HIV, HBV, or HCV; acute viral, bacterial, or fungal infection
- Significant psychiatric disorders/legal incapacity or a limited legal capacity
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00431561
Start Date
April 1 2003
End Date
March 1 2009
Last Update
December 3 2013
Active Locations (36)
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1
Universitätsklinik Innsbruck; Abteilung für Neurochirurgie
Innsbruck, Austria, 6020
2
Landes-Nervenklinik Wagner-Jauregg
Linz, Austria, 4020
3
Kaiser Franz Josef Spital, Abteilung für Neurologie
Vienna, Austria, 1100
4
Sarajishvili Institute of Clinical Neurology and Neurosurgery
Tbilisi, Georgia, 0114