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

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

Publications

Uckun FM, Qazi S, Hwang L, Trieu VN. Recurrent or Refractory High-Grade Gliomas Treated by Convection-Enhanced Delivery of a TGFbeta2-Targeting RNA Therapeutic: A Post-Hoc Analysis with Long-Term Follow-Up. Cancers (Basel). 2019 Nov 28;11(12):1892. doi: 10.3390/cancers11121892.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AP 12009	Antisense oligonucleotide	10 unknown	Other
Subject	AP 12009	Antisense oligonucleotide	80 unknown	Other
Comparator	Lomustine	Small molecule	—	—
Comparator	Temozolomide	Small molecule	200 mg/m2	—
Comparator	Vincristine	Small molecule	—	—
Comparator	procarbazine	Small molecule	—	—

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

Summary

Timeline

Publications

Drugs

Indications