Trial intelligence / Profile preview

ONCOVIRAC: TG6002 + 5-FC in Recurrent Glioblastoma

NCT03294486Phase 2

Key facts

Status: Unknown
Start: Oct 2017
Primary completion: May 2019
Countries: 1
Sponsor: Assistance publique - Hôpitaux de Paris

Drugs: TG6002
Conditions: glioblastoma (GBM)

Overview

Phase 2, open-label, single-arm trial of TG6002 in glioblastoma (GBM), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoints: Number of Participant with Dose Limiting Toxicities and Progression-Free Survival at 6 months. Status: unknown.

Design

1 arm

Study design: Non-randomizedOpen-label

TG6002 + 5-FC
Single arm for dose escalation and expansion.

Endpoints

Primary

Number of Participant with Dose Limiting ToxicitiesDay 1 to Day 26
Progression-Free Survival at 6 months6 months

Secondary

Recommended Phase 2 DoseStudy completion
Overall SurvivalUp to 51 months
Relative quantification of circulating viral DNADay 26
Blood pharmacokinetics of 5-FCDay 26
Blood pharmacokinetics of 5-FluorouracilDay 26
Viral shedding in saliva, urine and fecesDay 7
Metabolic ResponseDay 67
Humoral immune responseDay 39

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