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

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ClinicalTrials.gov Identifier: NCT02045589
Recruitment Status : Completed
First Posted : January 27, 2014
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
VCN Biosciences, S.L.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Metastatic Pancreatic Adenocarcinoma Genetic: VCN-01 Drug: Gemcitabine Drug: Abraxane® Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : September 2018

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability by means of Adverse Events (AEs) and laboratory data [ Time Frame: At least 6 months ]
  2. 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 Outcome Measures :
  1. Presence of VCN-01 in tumor [ Time Frame: Day 21-28 ]
    Determination of VCN-01 viral genome copies in tumor biopsy

  2. Viral Pharmacokinetics [ Time Frame: 48 h ]
    Determination of VCN-01 half-life by analyzing viral genome copies in blood

  3. Viral Shedding [ Time Frame: Up to day 71 ]
    At least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)

  4. 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

  5. Preliminary anti-tumor activity by Overall Response Rate (ORR) [ Time Frame: CT or MRI scans every 8 weeks until disease progression ]
  6. Preliminary anti-tumor activity by Progression Free Survival (PFS) [ Time Frame: CT or MRI scans every 8 weeks until disease progression ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045589


Locations
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Spain
Institut Català d'Oncologia
L'Hospitalet De Llobregat, Barcelona, Spain, 08908
Centro Integral Oncológico Clara Campal
Madrid, Spain, 25080
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
VCN Biosciences, S.L.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: VCN Biosciences, S.L.
ClinicalTrials.gov Identifier: NCT02045589    
Other Study ID Numbers: P-VCNA-002
2012-005556-42 ( EudraCT Number )
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Keywords provided by VCN Biosciences, S.L.:
Cancer
Pancreatic adenocarcinoma
Locally advanced
Metastatic
 Gemcitabine
Oncolytic virus
Abraxane®
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Albumin-Bound Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs