Phase II, single arm study of NOVOTTF-200A In bevacizumab-naive subjects with recurrent WHO grade III Malignant Astrocytoma
Summary
“This is a Phase 2 study in subjects with WHO Grade III Anaplastic Astrocytoma (G3 astrocytoma) who had progressive disease during first or second-line treatment and who have not previously received any BEV or any experimental agents.”
Description
Primary objective:
The primary objective will be to determine the efficacy of NOVOTTF-200A in recurrent anaplastic astrocytoma patients (6-month progression-free survival)
Secondary objectives:
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To evaluate the safety of NOVOTTF-200A in the subject population.
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To evaluate the efficacy of NOVOTTF-200A in the subject population.
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To see if the presence of ATRX, TERT promoter, IDH1 mutations, and/or MGMT promoter methylation, confers a better response to NOVOTTF-200A.
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To determine if the treatment significantly modifies the patient’s quality of life. The sponsor will use the Functional Assessment of Cancer Therapy (FACT) questionnaires:
1. FACT-Brain (FACT-Br)
2. FACT-Cognitive Function (FACT-Cog)
Exploratory objectives:
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To determine if the presence of pro-neural or mesenchymal phenotype (Cytoscan analysis) confers a better response to Novo-TTF.
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To determine if the in vitro sensitivity of the glioma cells derived from patient specimens before and after the NOVOTTF-200A treatment correlates with the patient’s response to treatment.
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