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NCT01478594 · ClinicalTrials.gov registry record · Phase 2
A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy
A Phase 2 study, sponsored by AVEO Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 265
- Enrollment target
NCT01478594: Completed Phase 2 study, sponsored by AVEO Pharmaceuticals.
NCT01478594 is a Phase 2 study that has completed, run by AVEO Pharmaceuticals. The registered enrollment target is 265 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01478594, a Phase 2 study, has completed, sponsored by AVEO Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 265 participants
- Enrollment target
Study Summary
The objective of this study is to compare the progression free survival (PFS), overall survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of response (DoR), quality of life, safety and tolerability of tivozanib in combination with mFOLFOX6 and bevacizumab in combination with mFOLFOX6.
Primary Outcome
The time from the date of randomization until objective tumor progression or death due to any cause. Objective tumor progression was determined through radiological imaging and based on the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1): Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of existing n
Interventions
- DRUG Bevacizumab
- DRUG Tivozanib
- DRUG mFOLFOX6
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
What the finished NCT01478594 record still lists
NCT01478594 is an interventional study that assigns participants to a tested intervention. The registered 265 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 (99% higher).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT01478594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01478594 about?
NCT01478594 is a clinical study titled "A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy". The objective of this study is to compare the progression free survival (PFS), overall survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of response (DoR), quality of life, safety and tolerability of tivozanib in combination with mFOLFOX6 and bevacizumab in comb...
What is the current status of trial NCT01478594?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 265 participants. The study started on 2011-12. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01478594?
The interventions under investigation include: Bevacizumab (DRUG), Tivozanib (DRUG), mFOLFOX6 (DRUG).
Who is sponsoring clinical trial NCT01478594?
This trial is sponsored by AVEO Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01478594's enrollment target sits among peer trials
265 210th of 2000 higher than 1,791 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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