drugset / Trial / NCT00431561

Phase IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma

NCT00431561

Phase 2 Completed 141 enrolled Isarna Therapeutics GmbH
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2003-04
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lomustine Small molecule
Comparator Temozolomide Small molecule 200 mg/m2
Comparator Vincristine Small molecule
Comparator procarbazine Small molecule
Subject trabedersen Antisense oligonucleotide 10 unknown Other
Subject trabedersen Antisense oligonucleotide 80 unknown Other