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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 is a Phase 1 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 11 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00860522
The ClinicalTrials.gov registry entry for NCT00860522 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which JVRS-100 is the first listed.
NCT00860522 reports 0 study locations.
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.
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