Who is sponsoring NCT00805376?

NCT00805376 is sponsored by DNAtrix, Inc..

What condition does NCT00805376 study?

NCT00805376 studies Brain Cancer, Central Nervous System Diseases.

What drugs are being tested in NCT00805376?

Interventions: DNX-2401, Tumor Removal.

What is the status of NCT00805376?

NCT00805376 is currently COMPLETED.

Last reviewed 2018-07-12 · How we verify

Phase I Trial of Conditionally Replication-Competent Adenovirus (DNX-2401, Formerly Known as Delta-24-RGD-4C) for Recurrent Malignant Gliomas

NCT00805376 Phase 1 COMPLETED

The goal of this clinical research study is to find the highest tolerable dose of DNX-2401 that can be injected directly into brain tumors and into the surrounding brain tissue where tumor cells can multiply. A second goal is to study how the new drug DNX-2401 affects brain tumor cells and the body in general.

Details

Lead sponsor	DNAtrix, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	37
Start date	2009-02
Completion	2015-02

Conditions

Brain Cancer
Central Nervous System Diseases

Interventions

DNX-2401
Tumor Removal

Primary outcomes

Maximum Tolerated Dose (MTD) DNX-2401 — Assessed during 14 day waiting period between doses (every 28 days).
Each cohort of three subjects each sequentially assigned to escalating doses of DNX-2401, with acceptable grade of neurotoxicity Common Toxicity Criteria (CTC) \< grade 3, related to the study drug, and according to standard Gehan phase I dose-escalating criteria for toxicity.

Countries

United States