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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.

Tracking Information
First Submitted Date May 7, 2018
First Posted Date May 18, 2018
Last Update Posted Date March 6, 2019
 
Descriptive Information
Brief Title Expanded Access for PSV Personalized Oncolytic Viruses
Official Title Expanded Access for PSV Personalized Oncolytic Viruses
Brief Summary A compassionate use, expanded access protocol for patients who have exhausted all standard therapy having progressed on chemotherapy and immunotherapy.
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.
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Cancer
Intervention Drug: PSV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03529539
Other Study ID Numbers PSV
Responsible Party EpicentRx, Inc.
Study Sponsor EpicentRx, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: John Morris, MD University of Cincinnati
PRS Account EpicentRx, Inc.
Verification Date March 2019