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NCT00615056 · ClinicalTrials.gov registry record · Phase 2
A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 171
- Enrollment target
NCT00615056: Completed Phase 2 study, sponsored by Pfizer.
NCT00615056 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 171 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00615056, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 171 participants
- Enrollment target
Study Summary
The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.
Primary Outcome
Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
Interventions
- DRUG AG-013736 (axitinib)
- DRUG Bevacizumab (avastin)
- DRUG FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])
- DRUG FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2008-03 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT00615056 record still lists
NCT00615056 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 4 interventions - of which AG-013736 (axitinib) is the first listed.
NCT00615056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00615056 about?
NCT00615056 is a clinical study titled "A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen". The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an...
What is the current status of trial NCT00615056?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 171 participants. The study started on 2008-03. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00615056?
The interventions under investigation include: AG-013736 (axitinib) (DRUG), Bevacizumab (avastin) (DRUG), FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]) (DRUG), FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) (DRUG).
Who is sponsoring clinical trial NCT00615056?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00615056's enrollment target sits among peer trials
171 398th of 2000 higher than 1,602 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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