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NCT03043391 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
A Phase 1 study, sponsored by Istari Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03043391 is a Phase 1 study that has completed, run by Istari Oncology. The registered enrollment target is 8 participants.
The verdict
NCT03043391, a Phase 1 study, has completed, sponsored by Istari Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of the study is to confirm the safety of the selected dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III or IV malignant glioma, but evidence for efficacy will also be sought. The primary objective is to confirm the safety of the selected dose of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED) in children with recurrent WHO Grade III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma) or WHO Grade IV malignant glioma (glioblastoma, gliosarcoma). A secondary objective is to estimate overall survival (OS) in this population.
Interventions
- BIOLOGICAL Polio/Rhinovirus Recombinant (PVSRIPO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-11-07 |
| Est. Completion | 2022-03-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03043391
The ClinicalTrials.gov registry entry for NCT03043391 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Istari Oncology, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Polio/Rhinovirus Recombinant (PVSRIPO) is the first listed.
NCT03043391 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03043391 about?
NCT03043391 is a clinical study titled "Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children". The purpose of the study is to confirm the safety of the selected dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III or IV malignant glioma, but evidence for efficacy will also be sought. The primary objective is to...
What is the current status of trial NCT03043391?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2017-11-07. Estimated completion is 2022-03-23.
What interventions are being tested in trial NCT03043391?
The interventions under investigation include: Polio/Rhinovirus Recombinant (PVSRIPO) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03043391?
This trial is sponsored by Istari Oncology, which has 8 total clinical trials registered on ClinicalTrials.gov.
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