NCT02045589

A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer

A Phase I, Multicenter, Open-label, Dose Escalation Study of Intratumoral Injections of VCN-01 Oncolytic Adenovirus With Intravenous Gemcitabine and Abraxane® in Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Theriva Biologics SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and tolerability of three intratumoral injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended phase II dose of VCN-01 combined with Abraxane®/gemcitabine.

Detailed description

Investigational treatment is a dose-escalation regimen consisting of three VCN-01 intratumoral injections (once every 28 days at the same dose) in combination with intravenous Abraxane® and gemcitabine.

Conditions

• Pancreatic Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
GENETIC	VCN-01	Genetically modified human adenovirus encoding human PH20 hyaluronidase
DRUG	Gemcitabine	1000 mg/m2 intravenous administration
DRUG	Abraxane®	125 mg/m2 intravenous administration

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-10-01
• Completion: 2018-09-01
• First posted: 2014-01-27
• Last updated: 2018-10-01

Locations

3 sites across 1 country: Spain