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NCT01322815 · ClinicalTrials.gov registry record · Phase 2
A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI
A Phase 2 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01322815: Clinical Trial Phase 2 study, sponsored by Georgetown University.
NCT01322815 is a Phase 2 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01322815, a Phase 2 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety of GI-4000 and see what effects (good and bad) it has against cancer over time. This study is also being done to measure the immune response to GI-4000. Study drug will be given in addition to a standard of care which is a standard therapy given to patients with your type of cancer (colon).
Primary Outcome
Clinical benefit rate is defined as the proportion of patients alive and free of progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients), assessed from first treatment with GI-4000. Progression is defined as CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of the target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of the target
Interventions
- DRUG chemotherapy and GI-4000
- DRUG GI-4000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-10 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
Why NCT01322815 stopped before completion
NCT01322815 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which chemotherapy and GI-4000 is the first listed.
NCT01322815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01322815 about?
NCT01322815 is a clinical study titled "A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI". The purpose of this study is to test the safety of GI-4000 and see what effects (good and bad) it has against cancer over time. This study is also being done to measure the immune response to GI-4000. Study drug will be given in addition to a standard of care which is a standard therapy given to pat...
What is the current status of trial NCT01322815?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2010-10. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01322815?
The interventions under investigation include: chemotherapy and GI-4000 (DRUG), GI-4000 (DRUG).
Who is sponsoring clinical trial NCT01322815?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01322815's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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