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
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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