Trial | NCT02045589  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    8
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.
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.
Study Started
Jan 31
2014
Primary Completion
Oct 31
2016
Study Completion
Sep 30
2018
Last Update
Oct 01
2018

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

Dose Escalation, Combination Experimental

Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine.

Criteria 

Inclusion Criteria:

Male/Female patients aged 18 years or over
Patients must provide written informed consent
Life expectancy above 3 months
Patients willing to comply with treatment follow-up, and to accept a biopsy at day 29 after initiation of the treatment
Patients with histologically confirmed diagnosis of unresectable pancreatic adenocarcinoma with symptoms related to the primary tumor. Abraxane® plus Gemcitabine should be the appropriate standard of care to be administered.
ECOG Performance status 0 or 1
Adequate baseline organ function (hematologic, liver, renal and nutritional)
Use a reliable method of contraception in fertile men and women

Exclusion Criteria:

Active infection or other serious illness or autoimmune disease
Treatment with live attenuated vaccines in the last three weeks
Known chronic liver disease (liver cirrhosis, chronic hepatitis)
Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion
Viral syndrome diagnosed during the two weeks before inclusion
Chronic immunosuppressive therapy
Known concurrent malignant hematologic or solid disease
Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile.
Patients receiving full-dose anticoagulant / antiplatelet therapy
Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency
No Results Posted