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NCT01008527 · ClinicalTrials.gov registry record · Phase 1
Phase I Oncovir Poly IC:LC and NY-ESO-1/gp100
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01008527: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01008527 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01008527, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this study is to determine what side effects CP 870,893 may cause when given with an immune stimulant called Oncovir poly IC:LC along with a melanoma vaccine. The CP 870,893, the Oncovir poly IC:LC and the melanoma vaccine are investigational drugs that have not been combined in patients before, and that have not been approved for sale by the Food and Drug Administration. The Oncovir poly IC:LC is intended to stimulate the body's immune system.
Primary Outcome
The overall goal is to define a safe and potentially effective dose and schedule of CP 870,893 with Oncovir poly IC:LC with a peptide vaccine with either Montanide ISA 51 VG or in aqueous solution for the adjuvant setting in high risk melanoma.
Interventions
- BIOLOGICAL Peptides
- DRUG CP 870,893
- BIOLOGICAL Oncovir poly IC:LC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT01008527 record still lists
NCT01008527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which Peptides is the first listed.
NCT01008527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01008527 about?
NCT01008527 is a clinical study titled "Phase I Oncovir Poly IC:LC and NY-ESO-1/gp100". The purpose of this study is to determine what side effects CP 870,893 may cause when given with an immune stimulant called Oncovir poly IC:LC along with a melanoma vaccine. The CP 870,893, the Oncovir poly IC:LC and the melanoma vaccine are investigational drugs that have not been combined in patie...
What is the current status of trial NCT01008527?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2009-10. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01008527?
The interventions under investigation include: Peptides (BIOLOGICAL), CP 870,893 (DRUG), Oncovir poly IC:LC (BIOLOGICAL).
Who is sponsoring clinical trial NCT01008527?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01008527's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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