Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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PSV
Eligibility Criteria
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Inclusion Criteria
* 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
* An active bacterial, fungal, or viral infection.
18 Years
MALE
No
Sponsors
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EpicentRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John Morris, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Other Identifiers
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PSV
Identifier Type: -
Identifier Source: org_study_id
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