drugset / Trial / NCT02045589

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

NCT02045589

Phase 1 Completed 8 enrolled Theriva Biologics SL
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-01
Primary completion
2016-10
Completion
2018-09

Drugs

EvaluationDrugModalityDoseRoute
Subject zabilugene almadenorepvec Unknown 1e+11 vg Intrathecal
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Paclitaxel Small molecule 125 mg/m2 Intravenous