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NCT01833273 · ClinicalTrials.gov registry record · Phase 1
Dose Evaluation Safety STudy IN Individuals With Astrocytoma Taking PolyMVA
A Phase 1 study, sponsored by Stony Brook University.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01833273: Completed Phase 1 study, sponsored by Stony Brook University.
NCT01833273 is a Phase 1 study that has completed, run by Stony Brook University. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01833273, a Phase 1 study, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
In order to test the investigators hypothesis that 8 teaspoons of POLYMVA is safe in a population of patients with grade IV brain astrocytoma (glioblastoma multiforme), the investigators will conduct an open-label, prospective, un-blinded study. The investigators expect that at least 70% of subjects will tolerate the supplement and complete the trial. The investigators expect no Serious Adverse Event to occur during this trial which is attributable to study compound. During this study, the investigators will also collect other qualitative data to be utilized for future double-blinded studies which will be aimed at determining whether grade IV astrocytoma patients who receive PolyMVA achieve a better quality of life during their chemo-therapeutic regimens versus grade IV astrocytoma patients who do not receive PolyMVA.
Primary Outcome
Adverse Events will be recorded throughout the course of the study and scaled for severity according to CTCAE v. 4.02. AE's will also be scaled for relatedness to the study compound and will be adjudicated by a DSMB. MRIs will be obtained at baseline, 26 weeks ans 34 weeks. We will look for disease progression according to MacDonald criteria. Blood work and urinalysis will also be obtained at every visit. Tolerability will be based upon subject questioning.
Interventions
- DRUG PolyMVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-07 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT01833273 record still lists
NCT01833273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which PolyMVA is the first listed.
NCT01833273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01833273 about?
NCT01833273 is a clinical study titled "Dose Evaluation Safety STudy IN Individuals With Astrocytoma Taking PolyMVA". In order to test the investigators hypothesis that 8 teaspoons of POLYMVA is safe in a population of patients with grade IV brain astrocytoma (glioblastoma multiforme), the investigators will conduct an open-label, prospective, un-blinded study. The investigators expect that at least 70% of subjects...
What is the current status of trial NCT01833273?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2010-07. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01833273?
The interventions under investigation include: PolyMVA (DRUG).
Who is sponsoring clinical trial NCT01833273?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01833273's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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