Overview

This trial is active, not recruiting.

Conditions pancreatic adenocarcinoma, metastatic pancreatic adenocarcinoma
Treatments vcn-01, gemcitabine, abraxane®
Phase phase 1
Sponsor VCN Biosciences, S.L.
Start date January 2014
End date October 2016
Trial size 18 participants
Trial identifier NCT02045589, 2012-005556-42, P-VCNA-002

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine.
vcn-01
Genetically modified human adenovirus encoding human PH20 hyaluronidase
gemcitabine
1000 mg/m2 intravenous administration
abraxane®
125 mg/m2 intravenous administration

Primary Outcomes

Measure
Safety and Tolerability by means of Adverse Events (AEs) and laboratory data
time frame: At least 6 months
Recommended Phase 2 Dose (RP2D) of VCN-01 in combination with Gemcitabine and Abraxane® by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities
time frame: At least 6 months

Secondary Outcomes

Measure
Presence of VCN-01 in tumor
time frame: Day 21-28
Viral Pharmacokinetics
time frame: 48 h
Viral Shedding
time frame: Up to day 71
Neutralizing antibodies anti-VCN-01
time frame: 30 days after end of treatment phase
Preliminary anti-tumor activity by Overall Response Rate (ORR)
time frame: CT or MRI scans every 8 weeks until disease progression
Preliminary anti-tumor activity by Progression Free Survival (PFS)
time frame: CT or MRI scans every 8 weeks until disease progression

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by VCN Biosciences, S.L..