Pancreatic Cancer with at least one hepatic metastasis MedDRA version: 18.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864
Conditions
Interventions
Product Name: ParvOryx
Product Code: ParvOryx
Pharmaceutical Form: Solution for injection/infusion
Sponsors
Oryx GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age over 18 years, - Informed consent, - Histologically confirmed disease - Disease progression despite first line therapy - Eligibility for chemotherapy with gemcitabine - ECOG performance scale 0 or 1, - Consent for the sampling of biological specimens - Adequate bone marrow and renal function - Hepatic enzymes within predefined range - Negative serology for HIV, HBV and HCV - Exlusion of pregnany - Use of adequate contraception in both genders Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Eligibility for surgical treatment, - Symptomatic cerebral, pulmonal, and/or ossear metastases, - Peritoneal carcinosis, Liver cirrhosis, Splenectomy - Recent hospitalization - Chemotherapy within 2 weeks prior to the first administration of the IMP, - Signs of active, systemic infection within 7 days prior to the study inclusion - Recent radiotherapy - Contraindications for CT, - Known allergy to iodinated contrast media, - Recent participation in another interventional trial - Presumed contact with pregnant women and/or infants <12 months of age within the 28 days after the first administration of the IMP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of anti-tumor effects of ParvOryx by means of chosen histo-immuno-pathological characteristics (Proof of Concept, PoC) ;Secondary Objective: Investigation of: - virus replication in the tumor tissue - the cellular immune response against viral proteins - humoral immune-response to H-1PV (ADA) - the PK of virus genomes in blood - virus shedding in feces, urine and saliva - tolerability and safety of the IMP - clinical outcome (PFS, OS);Primary end point(s): - Extent of metastatic necrosis and other pathological characteristics - Density of tumor infiltrating immune cells - Tissue content of cytokines and chemokines ;Timepoint(s) of evaluation of this end point: Individual schedule of evaluation up to 28 days or 2 months after the first Administration of the IMP | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Up to 6 months after the first administration of the IMP;Secondary end point(s): - NS-1 detection in the tumor material. - ELISPOT and FACS (viral Proteins). - ADA - qPCR in blood - Shedding of viral genomes in feces, urine and saliva - findings in physical examination, chosen laboratory parameters, ECG and adverse events - PFS and OS according to RECIST - Course of CA 19-9 in serum | — |
Countries
Germany
Outcome results
None listed