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

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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

Male or female 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 July 2016.
Information provided to ClinicalTrials.gov by VCN Biosciences, S.L..