APG101 in Glioblastoma
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|ClinicalTrials.gov Identifier: NCT01071837|
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : June 16, 2015
This is a phase II study of APG101 + reirradiation (RT) versus reirradiation. Patients suffering from a malignant brain tumor called glioblastoma having a first or second progression can be included. They will be randomized to RT or RT + APG101.
APG101 is a fusion protein (similar to an antibody) and will be administered as a weekly infusion. Patients can stay in this study as long as they benefit from the participation (no fixed end).
In this trial, 30-35 sites in Germany, Austria and Russia take part.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: APG101 Procedure: Blood drawing||Phase 2|
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 intravenous infusion.
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 physician.
MRI tumour imaging will be carried out every 6 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Active Comparator: Re-Irradiation
33% of the patients will be randomized to reirradiation (RT) alone. They will receive 36 Gy (2 Gy per fraction)
Procedure: Blood drawing
Blood drawings, e.g. for safety labs, abdominal ultrasound, ECG. Re-Irradiation is not considered a study procedure, but standard of care (inclusion criterion)
Experimental: Re-Irradiation + APG101
66% of the patients will be randomized to reirradiation (RT) + 400 mg APG101 weekly. They will receive 36 Gy (2 Gy per fraction) and 400 mg APG101 weekly as an intravenous infusion
400mg weekly as intravenous infusion
Other Name: Recombinant fusion protein
- 6 months rate of progression free survival (PFS6) [ Time Frame: 6 month ]
- Safety and tolerability of APG101 [ Time Frame: ongoing during study ]
- Progression-free survival [ Time Frame: until progression of underlying disease ]
- Objective response rates (OR) [ Time Frame: ongoing during study ]
- Duration of response (DR) in responders [ Time Frame: ongoing during study ]
- Overall survival [ Time Frame: until study and after end of study (by 8-weekly phone calls) ]
- Quality of life [ Time Frame: ongoing during study ]
- Cognitive function [ Time Frame: ongoing during study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071837
|Study Director:||Wolfgang Wick, MD||University Hospital Heidelberg, Dept. of Neurooncology, Germany|