Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT03450850
Brief 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.
Detailed 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:
* To evaluate the safety of NOVOTTF-200A in the subject population.
* To evaluate 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. Sponsor will use the Functional Assessment of Cancer Therapy (FACT) questionnaires:
* FACT-Brain (FACT-Br)
* FACT-Cognitive Function (FACT-Cog)
Exploratory Objectives:
* To determine if the presence of proneural or mesenchymal phenotype (Cytoscan analysis) confers a better response to NovoTTF.
* 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.
Study:
NCT03450850
Study Brief:
Protocol Section:
NCT03450850