A Phase II, Randomized, Open-label, Multi-centre Study of Weekly APG101 + Reirradiation Versus Reirradiation in the Treatment of Patients With First or Second Progression of Glioblastoma
In this phase II trial, patients with a recurrence / progression of glioblastoma (first or
second progression) either not being eligible for tumour resection or having macroscopic
residual tumour after resection of the recurrence can be included (tumor size must 1-4 cm in
T1-weighted MRI). They must be candidates for a re-irradiation and will then be randomized
in a 1:2 ratio to re-irradiation alone or re-irradiation + 400mg APG101 as a weekly
Radiotherapy (RT) is considered standard of care and not a study procedure. As prior
therapies, a first radiotherapy (maximal dose of 60 Gy; at least 8 months since the end of
preirradiation), a prior surgery (at least for histology) and at least one
Temozolomide-containing chemotherapy are mandatory; patients with prior treatment with
bevacizumab, iodine seeds and/or brachytherapy are not eligible. The patients' steroid dose
must be stable or decreasing upon inclusion.
The number of patients to be included in this study is up to 83 (depending on the
statistical 2-step SIMON design).
Primary objective: 6 months rate of progression free survival (PFS6). Subjects can
participate in this study as long as a clinical benefit is considered by the treating
MRI tumour imaging will be carried out every 6 weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
6 months rate of progression free survival (PFS6)
Wolfgang Wick, MD
University Hospital Heidelberg, Dept. of Neurooncology, Germany