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Parvovirus H-1 (ParvOryx) in Patients With Metastatic Inoperable Pancreatic Cancer (ParvOryx02)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Carcinoma, Pancreatic Ductal

Treatments

Drug: Parvovirus H-1 (H-1PV)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02653313
ParvOryx02

Details and patient eligibility

About

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.

Full description

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.

Initially four equal doses of ParvOryx will be administered intravenously on four consecutive days. Seven to fourteen days after the first intravenous administration the drug will be injected directly in a hepatic metastasis of the pancreatic cancer.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age at least 18 year,
  2. Ability to give informed consent,
  3. Histologically confirmed pancreatic ductal adenocarcinoma (PAD) with at least one measurable hepatic metastasis according to RECIST 1.1,
  4. Disease progression despite first line therapy (whatever chemotherapy regimen),
  5. Eligibility for second line chemotherapy with gemcitabine,
  6. ECOG performance scale 0 or 1,
  7. Consent for the sampling and investigations of biological specimens as scheduled by the trial protocol,
  8. Adequate bone marrow function: neutrophils >1.5 x 1E09/L, platelets >100 x 1E09/L, hemoglobin >9.0 g/dL,
  9. Liver function tests (LFT) within the following range: Bilirubin <3 x ULN (Upper Limit of Normal); ASAT and ALAT <5 x ULN,
  10. Adequate renal function: Creatinine <1.5 g/dL,
  11. Adequate blood clotting: aPTT <39 sec, INR <1.2,
  12. Normal thyroid function, i.e. TSH, fT3 and fT4 within the normal range (TSH: 0.4 - 4.0 mU/l, fT3: 2.0 - 4.2 ng/l, fT4: 8 - 18 ng/l)
  13. Negative serology for HIV, HBV and HCV,
  14. Negative Beta-HCG test in blood in woman of childbearing potential,
  15. Use of adequate contraception in both genders, i.e. use of double-effective method of contraception for the entire participation in the trial.

Exclusion criteria

  1. Eligibility for surgical treatment,
  2. Symptomatic cerebral, pulmonal, and/or osseous metastases,
  3. Peritoneal carcinosis,
  4. Liver cirrhosis,
  5. Splenectomy,
  6. Relevant respiratory impairment, corresponding to the grade IV or V of the MRC Breathlessness Scale (stops for breath after walking about 100 meters or after a few minutes on level ground, or too breathless to leave the house, or breathless when undressing),
  7. Positive anti-drug antibodies (ADAs) against ParvOryx,
  8. Hospitalization due to other conditions than the pancreatic cancer within the last 3 months,
  9. Chemotherapy within 2 weeks prior to the first administration of the IMP,
  10. Signs of active, systemic infection within 7 days prior to the study inclusion (clinical symptoms (cough, running nose, burning sensation while urinating, apparent skin or wound infection) and/or increase of fever and/or deterioration of infection-specific laboratory parameters beyond changes apparently driven by the underlying pancreatic cancer),
  11. Radiotherapy within 6 weeks prior to the study inclusion,
  12. Contraindications for CT,
  13. Known allergy to iodinated contrast media,
  14. Participation in another interventional trial within the last 30 days,
  15. Presumed contact with pregnant women and/or infants <12 months of age within two months after the first administration of the IMP.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

ParvOryx
Experimental group
Description:
ParvOryx given intravenously on four consecutive days (day 1 to 4) and intrametastatic six to thirteen days thereafter (day 7, 10 or 14).
Treatment:
Drug: Parvovirus H-1 (H-1PV)

Trial contacts and locations

1

There are currently no registered sites for this trial.

Timeline

Last updated: Nov 21, 2022

Start date

Dec 01, 2015 • 9 years ago

End date

May 01, 2018 • 6 years ago

Today

Jan 23, 2025

Sponsor of this trial

Lead Sponsor

Data sourced from clinicaltrials.gov