Parvovirus H-1 (ParvOryx) in Patients With Metastatic Inoperable Pancreatic Cancer

NCT02653313 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-11-21

No results posted yet for this study

Summary

Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis.

Conditions

  • Carcinoma, Pancreatic Ductal

Interventions

DRUG

Parvovirus H-1 (H-1PV)

Parvovirus H-1 administered at three increasing dose levels , according to the following schedule: i) 4 daily intravenous infusions of 10% of the total dose over 2 hours on 4 consecutive days, ii) direct injection of 60% of the total dose into a hepatic metastasis of the pancreatic cancer. The total dose levels are: 1E09, 5E09 and 1E10 pfu.

Sponsors & Collaborators

  • Oryx GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Bernard Huber, Dr. · Oryx GmbH & Co. KG

  • Guy Ungerechts, Prof. Dr. Dr. · National Center for Tumor Diseases, Heidelberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653313 on ClinicalTrials.gov