E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pancreatic Cancer with at least one hepatic metastasis |
Pankreaskarzinom mit mindestens einer Lebermetastase |
|
E.1.1.1 | Medical condition in easily understood language |
Pancreatic Cancer with at least one metastasis in the liver |
Bauchspeicheldrüsenkrebs mit mindestens einer Lebermetastase |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033605 |
E.1.2 | Term | Pancreatic cancer metastatic |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Investigation of anti-tumor effects of ParvOryx by means of chosen histo-immuno-pathological characteristics (Proof of Concept, PoC) |
|
E.2.2 | Secondary objectives of the trial |
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) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Extent of metastatic necrosis and other pathological characteristics
- Density of tumor infiltrating immune cells
- Tissue content of cytokines and chemokines
|
|
E.5.1.1 | 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 |
|
E.5.2 | 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
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 6 months after the first administration of the IMP |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |