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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed 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.

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.


Sponsor: Oryx GmbH & Co. KG

Current Primary Outcome:

  • 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 af

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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


    Original Secondary Outcome: Same as current

    Information By: Oryx GmbH & Co. KG

    Dates:
    Date Received: December 4, 2015
    Date Started: December 2015
    Date Completion: July 2017
    Last Updated: September 26, 2016
    Last Verified: September 2016