Glioblastoma Clinical Trial
Official title:
Efficacy and Safety of AP 12009 in Adult Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma as Compared to Standard Chemotherapy Treatment: A Randomized, Actively Controlled, Open Label Clinical Phase III Study.
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).
The purpose of this study is to compare the safety and efficacy of the 10 µM concentration of
AP 12009 and standard chemotherapy (temozolomide, BCNU, CCNU) in adult patients with
recurrent or refractory anaplastic astrocytoma (AA, WHO grade III) or secondary glioblastoma
(GBM, WHO grade IV). AP 12009 (trabedersen) is a phosphorothioate antisense
oligodeoxynucleotide specific for the mRNA of human Transforming Growth Factor beta 2
(TGF-beta-2), which is applied intratumorally. 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. In patients with high-grade glioma, the
TGF-beta-2 overexpression is associated with disease stage, clinical prognosis, and the
immunodeficient state of the patients. Main objective of the study is to determine survival
(rate) and tumor response.
Important note: Due to early trial termination, resulting in limited data availability, all
analyses remain descriptive by nature, only. No conclusive endpoint analysis can be
performed.
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