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Expanded Access for PSV Personalized Oncolytic Viruses (PSV)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529539
Expanded Access Status : No longer available
First Posted : May 18, 2018
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
EpicentRx, Inc.

Brief Summary:
A compassionate use, expanded access protocol for patients who have exhausted all standard therapy having progressed on chemotherapy and immunotherapy.

Condition or disease Intervention/treatment
Cancer Drug: PSV

Detailed Description:
Patients will receive intratumoral or subcutaneous injection of an oncolytic virus called PSV (short for Personalized Virus) 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.

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Expanded Access for PSV Personalized Oncolytic Viruses

Resource links provided by the National Library of Medicine




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Principal Investigator: John Morris, MD University of Cincinnati
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Responsible Party: EpicentRx, Inc.
ClinicalTrials.gov Identifier: NCT03529539    
Other Study ID Numbers: PSV
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Keywords provided by EpicentRx, Inc.:
Cancer