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Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of VCN-01 either administered alone or in combination with Abraxane®/Gemcitabine, and to determine the recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.


Clinical Trial Description

The study consists of three parts:

- Part I is a dose escalation study to determine the safety and tolerability of a single intravenous injection of VCN-01 alone

- In Part II the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine.

- In Part III the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine in a "delayed" schedule compared with Part II. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02045602
Study type Interventional
Source VCN Biosciences, S.L.
Contact
Status Completed
Phase Phase 1
Start date January 2014
Completion date January 2020

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