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NCT00860522 · ClinicalTrials.gov registry record · Phase 1
JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia
A Phase 1 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT00860522: Completed Phase 1 study, sponsored by Milton S. Hershey Medical Center.
NCT00860522 is a Phase 1 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00860522, a Phase 1 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, dose escalation study of JVRS-100. The study will proceed in 2 stages to minimize the number of patients treated at doses substantially below the recommended phase 2 dose. In stage 1, an accelerated titration schema will be followed with one patient at each dose level. Stage 2 will commence after a dose limiting toxicity is observed in stage 1 or after the maximum dose for stage 1 is reached. Stage 2 will follow a modified Fibonacci schema with 3-6 subjects at each dose level until a recommended phase 2 dose is determined. The cohort will then be expanded to a maximum of 12 patients to more fully evaluate the recommended phase 2 dose.
Primary Outcome
Toxicities will be assessed on day 30 of cycle 1. Establish dose limiting toxicity and a maximum tolerated dose recommended Phase 2 dose.
Interventions
- DRUG JVRS-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2009-03-01 |
| Est. Completion | 2017-02-20 |
| Phase | Phase 1 |
What the finished NCT00860522 record still lists
NCT00860522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which JVRS-100 is the first listed.
NCT00860522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00860522 about?
NCT00860522 is a clinical study titled "JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia". This is a Phase 1, open-label, dose escalation study of JVRS-100. The study will proceed in 2 stages to minimize the number of patients treated at doses substantially below the recommended phase 2 dose. In stage 1, an accelerated titration schema will be followed with one patient at each dose level....
What is the current status of trial NCT00860522?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2009-03-01. Estimated completion is 2017-02-20.
What interventions are being tested in trial NCT00860522?
The interventions under investigation include: JVRS-100 (DRUG).
Who is sponsoring clinical trial NCT00860522?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00860522's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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