Phase II, single arm study of NOVOTTF-200A In bevacizumab-naive subjects with recurrent WHO grade III Malignant Astrocytoma
“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.”
The primary objective will be to determine the efficacy of NOVOTTF-200A in recurrent anaplastic astrocytoma patients (6-month progression-free survival)
To evaluate the safety of NOVOTTF-200A in the subject population.
To evaluate the efficacy of NOVOTTF-200A in the subject population.
To see if the presence of ATRX, TERT promoter, IDH1 mutations, and/or MGMT promoter methylation, confers a better response to NOVOTTF-200A.
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)
To determine if the presence of pro-neural or mesenchymal phenotype (Cytoscan analysis) confers a better response to Novo-TTF.
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.