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

This study is currently recruiting participants.
Verified September 2016 by Oryx GmbH & Co. KG
Sponsor:
ClinicalTrials.gov Identifier:
NCT02653313
First Posted: January 12, 2016
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Oryx GmbH & Co. KG
  Purpose
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.

Condition Intervention Phase
Carcinoma, Pancreatic Ductal Drug: Parvovirus H-1 (H-1PV) Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Oryx GmbH & Co. KG:

Primary Outcome Measures:
  • Safety and tolerability of the IMP [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: findings in physical examinations

  • Safety and tolerability of the IMP [ Time Frame: Up to 6 months after treatment beginning ]
    Parameters: chosen laboratory parameters

  • Safety and tolerability of the IMP [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: ECG

  • Safety and tolerability of the IMP [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: adverse events

  • Humoral immuneresponse to the IMP [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Serum concentration of anti-drug antibodies (ADA)

  • Pharmacokinetics of viral genomes [Vg] [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Cmax in blood

  • Pharmacokinetics of viral genomes [Vg] [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: AUC in blood

  • Shedding of viral genomes [Vg] [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Concentration of Vg in feaces

  • Shedding of viral genomes [Vg] [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Concentration of Vg in urine

  • Shedding of viral genomes [Vg] [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Concentration of Vg in saliva


Secondary Outcome Measures:
  • Histo-immuno-pathological effects of the IMP in the hepatic metastasis [ Time Frame: Up to 2 months after treatment beginning ]
    Parameter: extent of tumor necrosis

  • Histo-immuno-pathological effects of the IMP in the hepatic metastasis [ Time Frame: Up to 2 months after treatment beginning ]
    Parameter: density of tumor infiltrating cells

  • Histo-immuno-pathological effects of the IMP in the hepatic metastasis [ Time Frame: Up to 2 months after treatment beginning ]
    Parameter: tissue content of cytokines

  • Histo-immuno-pathological effects of the IMP in the hepatic metastasis [ Time Frame: Up to 2 months after treatment beginning ]
    Parameter: tissue content of chemokines

  • Extent of virus replication in the hepatic metastasis [ Time Frame: Up to 2 months after treatment beginning ]
    Parameters: quantification of NS-1 protein in the metastatic tissue

  • Cellular immune response against viral proteins [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: ELISPOT

  • Cellular immune response against viral proteins [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: FACS

  • Clinical outcome [ Time Frame: Up to 6 months after treatment beginning ]
    Parameters: PFS, OS

  • Clinical outcome [ Time Frame: Up to 6 months after treatment beginning ]
    Parameter: Serum concentration of CA19-9


Estimated Enrollment: 7
Study Start Date: December 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ParvOryx
ParvOryx given intravenously on four consecutive days (day 1 to 4) and intrametastatic six to thirteen days thereafter (day 7, 10 or 14).
Drug: Parvovirus H-1 (H-1PV)

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.

Other Name: ParvOryx

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653313


Contacts
Contact: Guy Ungerechts, Prof. Dr. Dr. +49 6221 56 ext 38718 Guy.Ungerechts@nct-heidelberg.de
Contact: Jacek Hajda, Dr. +49 6221 56 ext 34507 Jacek.Hajda@med.uni-heidelberg.de

Locations
Germany
National Center for Tumor Diseases (NCT) Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Guy Ungerechts, Prof. Dr. Dr.    +49 6221 56 ext 38718    Guy.Ungerechts@nct-heidelberg.de   
Contact: Christoph Springfeld, PD Dr. Dr.    +49 6221 56 ext 38552    Christoph.Springfeld@nct-heidelberg.de   
Sponsors and Collaborators
Oryx GmbH & Co. KG
Investigators
Study Director: Bernard Huber, Dr. Oryx GmbH & Co. KG
Principal Investigator: Guy Ungerechts, Prof. Dr. Dr. National Center for Tumor Diseases, Heidelberg
  More Information

Responsible Party: Oryx GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT02653313     History of Changes
Other Study ID Numbers: ParvOryx02
First Submitted: December 4, 2015
First Posted: January 12, 2016
Last Update Posted: September 27, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary