NCT01817751

Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma

Phase 2 Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Glioblastoma
• Recurrent Adult Brain Neoplasm
• Malignant Glioma
• WHO Grade III Glioma

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given by mouth
DRUG	valproic acid	Given by mouth
DRUG	sildenafil citrate	Given by mouth

Timeline

• Start date: 2013-04-11
• Primary completion: 2020-08-27
• Completion: 2023-05-12
• First posted: 2013-03-25
• Last updated: 2024-07-17
• Results posted: 2021-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study