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NCT00655161 · ClinicalTrials.gov registry record · Phase 2
A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant S. Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation
A Phase 2 study, sponsored by GlobeImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00655161 is a Phase 2 study that has completed, run by GlobeImmune. The registered enrollment target is 24 participants.
The verdict
NCT00655161, a Phase 2 study, has completed, sponsored by GlobeImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment.
Interventions
- BIOLOGICAL GI-4000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-04 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00655161
The ClinicalTrials.gov registry entry for NCT00655161 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlobeImmune, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GI-4000 is the first listed.
NCT00655161 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00655161 about?
NCT00655161 is a clinical study titled "A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant S. Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation". This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment.
What is the current status of trial NCT00655161?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2008-04. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00655161?
The interventions under investigation include: GI-4000 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00655161?
This trial is sponsored by GlobeImmune, which has 4 total clinical trials registered on ClinicalTrials.gov.
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