Expanded Access for PSV Personalized Oncolytic Viruses

NCT03529539 | Unknown

• 1 other identifier: PSV
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cancer

Keywords

Cancer

Interventions

PSV DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EpicentRx, Inc.: lead

MeSH Terms

Conditions

Neoplasms

Study Officials

• John Morris, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 18, 2018
• Last Updated: March 6, 2019

Record last verified: 2019-03