NCT03450850

Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma

Phase II, Single Arm Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent WHO Grade III Malignant Astrocytoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Daniela A. Bota · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Astrocytoma, Grade III

Interventions

Type	Name	Description
DEVICE	NOVOTTF-200A	NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate \>= 75% (\>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.

Timeline

• Start date: 2020-05-21
• Primary completion: 2023-09-07
• Completion: 2025-08-07
• First posted: 2018-03-01
• Last updated: 2026-02-17
• Results posted: 2025-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study