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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: Completed Phase 1 study, sponsored by Istari Oncology.
NCT01491893 is a Phase 1 study that has completed, run by Istari Oncology. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MTD will be the highest dose level for which the probability that a dose escalation patient experiences a dose-limiting toxicity (DLT) is estimated to be less than 20%. Any Grade 3 or 4 toxicity that is not reversible within 2 weeks, or any life-threatening event, or treatment-related death will be considered a DLT. Any grade 2 or higher serious autoimmune toxicities particularly those affecting vital organs (e.g. cardiac, renal, CNS) will be considered a DLT. 50% Tissue Culture Infective Do
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 |
What the finished NCT01491893 record still lists
NCT01491893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO) is the first listed.
NCT01491893 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01491893's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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