intratumoral administration of ParvOryx in patients with metastatic, inoperable pancreatic cancer
- Conditions
- Pancreatic Cancer with at least one hepatic metastasisMedDRA version: 18.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-001119-11-DE
- Lead Sponsor
- Oryx GmbH & Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: <br>- virus replication in the tumor tissue<br>- the cellular immune response against viral proteins<br>- humoral immune-response to H-1PV (ADA)<br>- the PK of virus genomes in blood <br>- virus shedding in feces, urine and saliva<br>- tolerability and safety of the IMP <br>- clinical outcome (PFS, OS);Primary end point(s): - Extent of metastatic necrosis and other pathological characteristics<br>- Density of tumor infiltrating immune cells <br>- Tissue content of cytokines and chemokines <br>;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 Outcome Measures
Name Time Method 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.<br>- ELISPOT and FACS (viral Proteins). <br>- ADA<br>- qPCR in blood<br>- Shedding of viral genomes in feces, urine and saliva <br>- findings in physical examination, chosen laboratory parameters, ECG and adverse events<br>- PFS and OS according to RECIST<br>- Course of CA 19-9 in serum <br>