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NCT00906243 · ClinicalTrials.gov registry record · Phase 1
RNActive®-Derived Therapeutic Vaccine
A Phase 1 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00906243: Clinical Trial Phase 1 study, sponsored by University of Florida.
NCT00906243 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00906243, a Phase 1 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase I/IIa open, uncontrolled, prospective study, to be conducted in an out-patient setting. The present study is one of two clinical trials of the RNActive®-derived vaccine CV9103 being conducted concurrently in the US and Europe, which represent the first clinical trials conducted for this novel vaccine. The Phase I part of the study consists of a staggered inclusion of subjects in two cohorts of 3, to confirm the safety of the intended dose (320 µg RNA per antigen), with a lower dose to be considered in case of dose-limiting toxicity (DLT) being reported in greater than or equal to 2 out of 3-6 subjects; in this way, the recommended dose (RD) for the Phase IIa part of the study will be established. In the Phase IIa part of the study, additional subjects will be included at the RD, to confirm the safety and explore the activity of that dose.
Primary Outcome
Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0: 1. All Categories equal or greater than grade 3 2. Allergy/autoimmunity equal or greater than grade 2 3. Dosing delay greater than 48 hours due to toxicity All adverse events will be graded and documented according to Common Terminology Criteria for Adverse Events version 3.0.
Interventions
- BIOLOGICAL CV9103
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2009-05 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
Why NCT00906243 stopped before completion
NCT00906243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which CV9103 is the first listed.
NCT00906243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00906243 about?
NCT00906243 is a clinical study titled "RNActive®-Derived Therapeutic Vaccine". This is a Phase I/IIa open, uncontrolled, prospective study, to be conducted in an out-patient setting. The present study is one of two clinical trials of the RNActive®-derived vaccine CV9103 being conducted concurrently in the US and Europe, which represent the first clinical trials conducted for t...
What is the current status of trial NCT00906243?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2009-05. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00906243?
The interventions under investigation include: CV9103 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00906243?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00906243's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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