Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 3:15 PM
Study NCT ID:
NCT03450850
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2018-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma
Sponsor:
Daniela A. Bota
Organization:
Study Overview
Official Title:
Phase II, Single Arm Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent WHO Grade III Malignant Astrocytoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UCI 16-56 | OTHER | UCI CFCCC | View |