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NCT01491893 · ClinicalTrials.gov registry record · Phase 1
PVSRIPO for Recurrent Glioblastoma (GBM)
A Phase 1 study, sponsored by Istari Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01491893 is a Phase 1 study that has completed, run by Istari Oncology. The registered enrollment target is 61 participants.
The verdict
NCT01491893, a Phase 1 study, has completed, sponsored by Istari Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
Purpose of the Study: To determine the maximally tolerated dose (MTD) and the Recommended Phase 2 Dose (RP2D) of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED). To obtain correlative mechanistic evidence of PVSRIPO's effects on infected WHO Grade IV malignant glioma tumors and to estimate progression-free survival (PFS) and overall survival (OS) in recurrent WHO Grade IV malignant glioma patients. To obtain information about clinical response rates to intratumoral inoculation of PVSRIPO. To estimate the efficacy of PVSRIPO administered at the optimal dose.
Interventions
- BIOLOGICAL Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2012-04-25 |
| Est. Completion | 2021-10-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01491893
The ClinicalTrials.gov registry entry for NCT01491893 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 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 Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO) is the first listed.
NCT01491893 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01491893 about?
NCT01491893 is a clinical study titled "PVSRIPO for Recurrent Glioblastoma (GBM)". Purpose of the Study: To determine the maximally tolerated dose (MTD) and the Recommended Phase 2 Dose (RP2D) of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED). To obtain correlative mechanistic evidence of PVSRIPO's effects on infected WHO Grade IV malignant glioma tu...
What is the current status of trial NCT01491893?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2012-04-25. Estimated completion is 2021-10-01.
What interventions are being tested in trial NCT01491893?
The interventions under investigation include: Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01491893?
This trial is sponsored by Istari Oncology, which has 8 total clinical trials registered on ClinicalTrials.gov.
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