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Carcinoma, Pancreatic DuctalPhase 1/2ParvOryx02NCT02653313

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

A Phase 1/2 study testing Parvovirus H-1 (H-1PV) in people with Carcinoma, Pancreatic Ductal, run by Oryx GmbH & Co. KG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Pancreatic Ductal
What is being tested?
Parvovirus H-1 (H-1PV)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteGermany
Study dates
Dec 2015to May 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Eligibility for surgical treatment,
  • Symptomatic cerebral, pulmonal, and/or osseous metastases,
  • Peritoneal carcinosis,
  • Liver cirrhosis,
  • Splenectomy,
  • 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),
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  • Positive anti-drug antibodies (ADAs) against ParvOryx,
  • Hospitalization due to other conditions than the pancreatic cancer within the last 3 months,
  • 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 (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),
  • Radiotherapy within 6 weeks prior to the study inclusion,
  • Contraindications for CT,
  • Known allergy to iodinated contrast media,
  • Participation in another interventional trial within the last 30 days,
  • Presumed contact with pregnant women and/or infants <12 months of age within two months after the first administration of the IMP.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • National Center for Tumor Diseases (NCT)

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

About this study

Official title: A Non-controlled, Single Arm, Open Label, Phase II Study of Intravenous and Intratumoral Administration of ParvOryx in Patients With Metastatic, Inoperable Pancreatic Cancer

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.

Read the detailed 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.

Being tested
Parvovirus H-1 (H-1PV)
Medical subject headings
Carcinoma, Pancreatic Ductal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parvovirus H-1 (H-1PV)Drug

    Also called ParvOryx

    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.

Study groups in NCT02653313
Study groupRoleWhat they receive
ParvOryxExperimentalParvOryx given intravenously on four consecutive days (day 1 to 4) and intrametastatic six to thirteen days thereafter (day 7, 10 or 14).
Receives: Drug: Parvovirus H-1 (H-1PV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of the IMP

    Parameter: findings in physical examinations

    Measured: Up to 6 months after treatment beginning

  2. Safety and tolerability of the IMP

    Parameters: chosen laboratory parameters

    Measured: Up to 6 months after treatment beginning

  3. Safety and tolerability of the IMP

    Parameter: ECG

    Measured: Up to 6 months after treatment beginning

  4. Safety and tolerability of the IMP

    Parameter: adverse events

    Measured: Up to 6 months after treatment beginning

  5. Humoral immuneresponse to the IMP

    Parameter: Serum concentration of anti-drug antibodies (ADA)

    Measured: Up to 6 months after treatment beginning

  6. Pharmacokinetics of viral genomes [Vg]

    Parameter: Cmax in blood

    Measured: Up to 6 months after treatment beginning

  7. Pharmacokinetics of viral genomes [Vg]

    Parameter: AUC in blood

    Measured: Up to 6 months after treatment beginning

  8. Shedding of viral genomes [Vg]

    Parameter: Concentration of Vg in feaces

    Measured: Up to 6 months after treatment beginning

  9. Shedding of viral genomes [Vg]

    Parameter: Concentration of Vg in urine

    Measured: Up to 6 months after treatment beginning

  10. Shedding of viral genomes [Vg]

    Parameter: Concentration of Vg in saliva

    Measured: Up to 6 months after treatment beginning

Secondary outcomes (9)

  1. Histo-immuno-pathological effects of the IMP in the hepatic metastasis

    Parameter: extent of tumor necrosis

    Measured: Up to 2 months after treatment beginning

  2. Histo-immuno-pathological effects of the IMP in the hepatic metastasis

    Parameter: density of tumor infiltrating cells

    Measured: Up to 2 months after treatment beginning

  3. Histo-immuno-pathological effects of the IMP in the hepatic metastasis

    Parameter: tissue content of cytokines

    Measured: Up to 2 months after treatment beginning

  4. Histo-immuno-pathological effects of the IMP in the hepatic metastasis

    Parameter: tissue content of chemokines

    Measured: Up to 2 months after treatment beginning

  5. Extent of virus replication in the hepatic metastasis

    Parameters: quantification of NS-1 protein in the metastatic tissue

    Measured: Up to 2 months after treatment beginning

  6. Cellular immune response against viral proteins

    Parameter: ELISPOT

    Measured: Up to 6 months after treatment beginning

  7. Cellular immune response against viral proteins

    Parameter: FACS

    Measured: Up to 6 months after treatment beginning

  8. Clinical outcome

    Parameters: PFS, OS

    Measured: Up to 6 months after treatment beginning

  9. Clinical outcome

    Parameter: Serum concentration of CA19-9

    Measured: Up to 6 months after treatment beginning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02653313
Sponsor's protocol ID
ParvOryx02
Acronym
ParvOryx02
Status last verified
Mar 2019
First submitted
4 Dec 2015
Last updated
21 Nov 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Hajda J, Lehmann M, Krebs O, Kieser M, Geletneky K, Jager D, Dahm M, Huber B, Schoning T, Sedlaczek O, Stenzinger A, Halama N, Daniel V, Leuchs B, Angelova A, Rommelaere J, Engeland CE, Springfeld C, Ungerechts G. A non-controlled, single arm, open label, phase II study of intravenous and intratumoral administration of ParvOryx in patients with metastatic, inoperable pancreatic cancer: ParvOryx02 protocol. BMC Cancer. 2017 Aug 29;17(1):576. doi: 10.1186/s12885-017-3604-y.

    PubMed 28851316

  • Hajda J, Leuchs B, Angelova AL, Frehtman V, Rommelaere J, Mertens M, Pilz M, Kieser M, Krebs O, Dahm M, Huber B, Engeland CE, Mavratzas A, Hohmann N, Schreiber J, Jager D, Halama N, Sedlaczek O, Gaida MM, Daniel V, Springfeld C, Ungerechts G. Phase 2 Trial of Oncolytic H-1 Parvovirus Therapy Shows Safety and Signs of Immune System Activation in Patients With Metastatic Pancreatic Ductal Adenocarcinoma. Clin Cancer Res. 2021 Oct 15;27(20):5546-5556. doi: 10.1158/1078-0432.CCR-21-1020. Epub 2021 Aug 23.

    PubMed 34426438

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Parvovirus H-1 (H-1PV) in people with Carcinoma, Pancreatic Ductal, run by Oryx GmbH & Co. KG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of the IMP (time frame: Up to 6 months after treatment beginning). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02653313, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.

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