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Expanded Access Non Emergency Use Single Subject Study Protocol for Metastatic Neuroendocrine Tumor of the Pancreas (PSV2)

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ClinicalTrials.gov Identifier: NCT03529539
Expanded Access Status : No longer available
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
EpicentRx, Inc.

Brief Summary:
A single patient protocol for intermediate grade nonfunctional metastatic pancreatic neuroendocrine disease that has exhausted all standard therapy having progressed on chemotherapy and immunotherapy.

Condition or disease Intervention/treatment
Neuroendocrine Tumor Drug: PSV2

Detailed Description:
This patient will receive intratumoral injection of an oncolytic virus called PSV2 (short for Personalized Virus-2) every other week until the occurrence of immune related RECIST progression, intolerable toxicity, change to another anti-cancer treatment due to lack of apparent benefit, or personal choice.

Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: SAFETY NET: PSV2 Expanded Access Non Emergency Use Single Subject Study Protocol for Metastatic Neuroendocrine Tumor (NET) of the Pancreas



Intervention Details:
  • Drug: PSV2
    Other Name: SAFETY NET

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Criteria

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form.
  • Measurable or evaluable disease with least one (1) tumor that is accessible to intratumoral injection.
  • Eastern Cooperative Group (ECOG) performance status is 0-3 at Screening.
  • Acceptable liver function at Screening, as evidenced by:

    • Bilirubin ≤ 3.0 X upper limit of normal (ULN) since this patient has
    • been diagnosed with Gilbert's Disease
  • AST (SGOT) and ALT (SGPT) ≤ 5 X ULN.
  • Serum creatinine < 3 x institution upper limit of normal.
  • Patient has acceptable hematologic status at Screening, as evidenced by:

    • Absolute neutrophil count ≥ 1,500 cells/mm3; and
    • Platelet count ≥ 70,000/mm3; and
    • Hemoglobin (HGB) ≥ 8.5 g/dL.
  • Medically acceptable contraception.
  • Willingness to comply with all protocol procedures, evaluations and rescue measures.

Exclusion Criteria:

  • Presence of a serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder.
  • An active bacterial, fungal, or viral infection.

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): NCT03529539


Sponsors and Collaborators
EpicentRx, Inc.
Investigators
Principal Investigator: John Morris, MD University of Cincinnati

Responsible Party: EpicentRx, Inc.
ClinicalTrials.gov Identifier: NCT03529539     History of Changes
Other Study ID Numbers: PSV2
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Keywords provided by EpicentRx, Inc.:
neuroendocrine disease of the pancreas.

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Pancrelipase
Pancreatin
Gastrointestinal Agents