NCT02045589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

2.8 years

First QC Date

January 21, 2014

Last Update Submit

September 27, 2018

Conditions

Pancreatic AdenocarcinomaMetastatic Pancreatic Adenocarcinoma

Keywords

CancerPancreatic adenocarcinomaLocally advancedMetastaticGemcitabineOncolytic virusAbraxane®

Outcome Measures

Primary Outcomes (2)

  • Safety and Tolerability by means of Adverse Events (AEs) and laboratory data

    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

    At least 6 months

Secondary Outcomes (6)

  • Presence of VCN-01 in tumor

    Day 21-28

  • Viral Pharmacokinetics

    48 h

  • Viral Shedding

    Up to day 71

  • Neutralizing antibodies anti-VCN-01

    30 days after end of treatment phase

  • Preliminary anti-tumor activity by Overall Response Rate (ORR)

    CT or MRI scans every 8 weeks until disease progression

  • +1 more secondary outcomes

Study Arms (1)

Dose Escalation, Combination

EXPERIMENTAL

Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine.

Genetic: VCN-01Drug: GemcitabineDrug: Abraxane®

Interventions

VCN-01GENETIC

Genetically modified human adenovirus encoding human PH20 hyaluronidase

Dose Escalation, Combination
GemcitabineDRUG

1000 mg/m2 intravenous administration

Dose Escalation, Combination
Abraxane®DRUG

125 mg/m2 intravenous administration

Dose Escalation, Combination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Centro Integral Oncológico Clara Campal

Madrid, 25080, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Related Publications (1)

  • Bazan-Peregrino M, Garcia-Carbonero R, Laquente B, Alvarez R, Mato-Berciano A, Gimenez-Alejandre M, Morgado S, Rodriguez-Garcia A, Maliandi MV, Riesco MC, Moreno R, Ginesta MM, Perez-Carreras M, Gornals JB, Prados S, Perea S, Capella G, Alemany R, Salazar R, Blasi E, Blasco C, Cascallo M, Hidalgo M. VCN-01 disrupts pancreatic cancer stroma and exerts antitumor effects. J Immunother Cancer. 2021 Nov;9(11):e003254. doi: 10.1136/jitc-2021-003254.

    PMID: 35149591DERIVED

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

GemcitabineAlbumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 27, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2016

Study Completion

September 1, 2018

Last Updated

October 1, 2018

Record last verified: 2018-09

Locations

ES(3)