A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer
NCT ID: NCT02045589
Last Updated: 2018-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2014-01-31
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation, Combination
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
Interventions
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VCN-01
Genetically modified human adenovirus encoding human PH20 hyaluronidase
Gemcitabine
1000 mg/m2 intravenous administration
Abraxane®
125 mg/m2 intravenous administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Theriva Biologics SL
INDUSTRY
Responsible Party
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Locations
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Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
Centro Integral Oncológico Clara Campal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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References
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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.
Other Identifiers
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2012-005556-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P-VCNA-002
Identifier Type: -
Identifier Source: org_study_id
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