drugset / Trial / NCT00761280
Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma
RandomizedParallel-groupOpen-labelTreatment
Summary
In this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed recurrent or refractory anaplastic astrocytoma (WHO grade III) or secondary glioblastoma (WHO grade IV).
Timeline
- Start
- 2008-12
- Primary completion
- 2012-02
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lomustine | Small molecule | 110 mg/m2 | — |
| Comparator | Temozolomide | Small molecule | 200 mg/m2 | — |
| Comparator | carmustine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | trabedersen | Antisense oligonucleotide | 10 unknown | Other |