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NCT00612586 · ClinicalTrials.gov registry record · Phase 2
Study of Enzastaurin With 5-Fluorouracil/Leucovorin (5-FU/LV) Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colon Cancer
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 117
- Enrollment target
NCT00612586: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT00612586 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 117 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00612586, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 117 participants
- Enrollment target
Study Summary
This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients with Metastatic Colorectal Cancer.
Primary Outcome
PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. Progressive disease was determined using a modified version of Response Evaluation Criteria in Solid Tumor (RECIST) Assessment and was defined as at least a 20% increase in sum of longest diameter of target lesions. Time to disease progression was censored at the date of death if death was due to other cause.
Interventions
- DRUG Placebo
- DRUG Leucovorin (LV)
- DRUG 5-fluorouracil (5-FU)
- DRUG Enzastaurin
- DRUG Bevacizumab (Bev)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT00612586 record still lists
NCT00612586 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00612586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00612586 about?
NCT00612586 is a clinical study titled "Study of Enzastaurin With 5-Fluorouracil/Leucovorin (5-FU/LV) Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colon Cancer". This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients...
What is the current status of trial NCT00612586?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2008-02. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00612586?
The interventions under investigation include: Placebo (DRUG), Leucovorin (LV) (DRUG), 5-fluorouracil (5-FU) (DRUG), Enzastaurin (DRUG), Bevacizumab (Bev) (DRUG).
Who is sponsoring clinical trial NCT00612586?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00612586's enrollment target sits among peer trials
117 623rd of 2000 higher than 1,378 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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