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Trial record 3 of 4 for:    VCN-01

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE January 21, 2014
First Posted Date  ICMJE January 27, 2014
Last Update Posted Date October 1, 2018
Actual Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2014)
  • 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 by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities [ Time Frame: At least 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
  • Presence of VCN-01 in tumor [ Time Frame: Day 21-28 ]
    Determination of VCN-01 viral genome copies in tumor biopsy
  • Viral Pharmacokinetics [ Time Frame: 48 h ]
    Determination of VCN-01 half-life by analyzing viral genome copies in blood
  • Viral Shedding [ Time Frame: Up to day 71 ]
    At least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)
  • 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
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2014)
  • Viral Pharmacokinetics [ Time Frame: 48 h ]
    Determination of VCN-01 half-life by analyzing viral genome copies in blood
  • Viral Shedding [ Time Frame: Up to day 71 ]
    At least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)
  • 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
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Adenocarcinoma
  • Metastatic Pancreatic Adenocarcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Dose Escalation, Combination
Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine.
Interventions:
  • Genetic: VCN-01
  • Drug: Gemcitabine
  • Drug: Abraxane®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2018)
8
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2014)
30
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02045589
Other Study ID Numbers  ICMJE P-VCNA-002
2012-005556-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VCN Biosciences, S.L.
Study Sponsor  ICMJE VCN Biosciences, S.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account VCN Biosciences, S.L.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP