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NCT00678392 · ClinicalTrials.gov registry record · Phase 3
Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 723
- Enrollment target
NCT00678392: Completed Phase 3 study, sponsored by Pfizer.
NCT00678392 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 723 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00678392, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 723 participants
- Enrollment target
Study Summary
The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.
Primary Outcome
PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: \>=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-ta
Interventions
- DRUG Sorafenib
- DRUG Axitinib (AG-013736)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 723 participants |
| Start Date | 2008-09-03 |
| Est. Completion | 2016-02-25 |
| Phase | Phase 3 |
What the finished NCT00678392 record still lists
NCT00678392 is an interventional study that assigns participants to a tested intervention. The registered 723 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Sorafenib is the first listed.
NCT00678392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00678392 about?
NCT00678392 is a clinical study titled "Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer". The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.
What is the current status of trial NCT00678392?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 723 participants. The study started on 2008-09-03. Estimated completion is 2016-02-25.
What interventions are being tested in trial NCT00678392?
The interventions under investigation include: Sorafenib (DRUG), Axitinib (AG-013736) (DRUG).
Who is sponsoring clinical trial NCT00678392?
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 NCT00678392's enrollment target sits among peer trials
723 492nd of 2000 higher than 1,507 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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