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

September 27, 2018 updated by: VCN Biosciences, S.L.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de octubre
      • Madrid, Spain, 25080
        • Centro Integral Oncologico Clara Campal
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
        • Institut Catala d'Oncologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation, Combination
Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability by means of Adverse Events (AEs) and laboratory data
Time Frame: At least 6 months
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
At least 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of VCN-01 in tumor
Time Frame: Day 21-28
Determination of VCN-01 viral genome copies in tumor biopsy
Day 21-28
Viral Pharmacokinetics
Time Frame: 48 h
Determination of VCN-01 half-life by analyzing viral genome copies in blood
48 h
Viral Shedding
Time Frame: Up to day 71
At least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)
Up to day 71
Neutralizing antibodies anti-VCN-01
Time Frame: 30 days after end of treatment phase
At least up to 6 months follow-up in patients at the MTD
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
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
CT or MRI scans every 8 weeks until disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VCN Biosciences, S.L.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-VCNA-002
  • 2012-005556-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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