Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT01817751
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2013-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
Phase 2 Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma
Status:
COMPLETED
Status Verified Date:
2024-06
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:
The purpose of this research study is to test the safety, tolerability, and effectiveness of the combination of three drugs, sorafenib (Nexavar®), valproic acid (Depakote®), and sildenafil (Viagra®), when used to treat high-grade glioma, a type of brain tumor.
Detailed Description:
The study is a single-center, open-label phase 2 study, with an early stopping rule in place for safety. The trial will include patients with recurrent or progressive high-grade glioma.
The trial will be conducted in an adaptive design, with a Simon's mini-max 2-stage design incorporating an interim analysis for efficacy
The trial will be conducted in an adaptive design, with a Simon's mini-max 2-stage design incorporating an interim analysis for efficacy
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HM14816 | OTHER | VCU IRB | View | |
| NCI-2013-00705 | OTHER | NCI | View | |
| P30CA016059 | NIH | None | https://reporter.nih.gov/quic… | View |